WORLD TRADE  
ORGANIZATION  IP/C/W/369/Rev.1 
9 March 2006 
 
 (06-1042) 
Council for Trade-Related Aspects 
of Intellectual Property Rights  
 
 
 
REVIEW OF THE PROVISIONS OF ARTICLE 27.3(B) 
 
SUMMARY OF ISSUES RAISED AND POINTS MADE 
 
Note by the Secretariat  
 
Revision  
 
 
 
    
TABLE OF CONTENTS                PAGE 
 
I.
 INTRODUCTION ................................................................................................................... .2 
II. ISSUES RELATING TO THE PATENT PROVISIONS OF ARTICLE 27.3(B) ..............2  
A. GENERAL ISSUES ............................................................................................................2  
B. SCOPE OF EXCEPTIONS TO PATENTABILITY IN ARTICLE 27.3( B) ....................................7  
C. ETHICAL EXCEPTIONS TO PATENTABILITY AND ARTICLE 27.2.....................................10  
D. CONDITIONS OF PATENTABILITY IN ARTICLE 27.1  AND  PLANT AND ANIMAL 
INVENTIONS ..................................................................................................................12  
III. ISSUES RELATING TO THE SUI GENERIS  PROTECTION OF PLANT 
VARIETIES ...................................................................................................................... ......14  
A. GENERAL ISSUES WITH RESPECT TO PLANT VARIETY PROTECTION ..............................14  
B. "EFFECTIVE SUI GENERIS  SYSTEMS " OF PROTECTION ....................................................16  
C. RELATIONSHIP BETWEEN THE TRIPS  REQUIREMENT TO HAVE AN EFFECTIVE 
SUI GENERIS  SYSTEM AND THE UPOV  CONVENTION ....................................................20  
D. RELATIONSHIP BETWEEN  SUI GENERIS  PROTECTION OF PLANT VARIETIES AND 
TRADITIONAL KNOWLEDGE AND FARMERS ' RIGHTS .....................................................23  
IV. TRANSFER OF TECHNOLOGY ........................................................................................24  
V. INFORMATION ON NATIONAL LEGISLATION, PRACTICES AND 
EXPERIENCES .................................................................................................................... ..25 
ANNEX .......................................................................................................................... .......................26  
 This document has been prepa red under the Secretariat's own 
responsibility and without prejudice to the positions of Members 
and to their rights and obligations under the WTOIP/C/W/369/Rev.1 
Page 2  
 
  I. INTRODUCTION 
1. At its meeting of 17-19 September 2002 the Counc il for TRIPS requested the Secretariat to 
periodically update its summary notes on issues rais ed and points made in the Council's work on three 
items of its agenda, namely, the review of the pr ovisions of Article 27.3 (b) in IP/C/W/369;  the 
relationship between the TRIPS Agreement and th e Convention on Biological Diversity (CBD) in 
IP/C/W/368;  and the protection of traditional know ledge and folklore in IP/C/W/370, not necessarily 
after every meeting, but when significant new mate rial had been presented.  The present document, 
which replaces IP/C/W/369, responds to this request  by including the points that have been made 
more specifically with respect to the review of th e provisions of Article 27.3(b) since the circulation 
of the original note. 
2. This note, like the original note, seeks to su mmarize the relevant material presented to the 
TRIPS Council, whether in written or oral form, and lists all the relevant doc umentation tabled in the 
Council since 1999.  To avoid undue duplication, cr oss-references to the other two notes or to other 
sections of this note have been made in certain pl aces.  In accordance with the mandate given to the 
Secretariat, the note only contains issues raised and points made by delegations in the Council for 
TRIPS.  It does not cover the documentation of the Committee on Trade and Environment and of the 
General Council, unless the relevant paper has also been circulated as a Council for TRIPS document, 
nor the discussions in the Director-General's consultative process on outstanding implementation issues.  The relevant documentation is listed in the Anne x to this note.  It is referred to in the footnotes 
which reflect the sources for the points made in the compilation.  In many cases, the same point has been made more than once;  the footnotes do not purport to contain references to all such occasions. 
3. It is emphasized that this note is an attempt to  summarize the work done so far.  By its very 
nature, it cannot include a full reflection of all the in terventions made and documents submitted.  It is 
structured around the issues raised rather than the positions of individual Members.  Therefore any 
reader wishing to appreciate fully the position of a particular Member should consult the statements 
made and any papers submi tted by that Member.   
4. This note is divided into three major sections.  The first concerns issues relating to the patent 
provisions of Article 27.3(b), the second concerns issues relating to the sui generis  protection of plant 
varieties and the third concerns issues relating to th e transfer of technology.  There is also a final 
section which provides information on  national legislation, practices and experiences with respect to 
this agenda item. 
II. ISSUES RELATING TO THE PATENT PROVISIONS OF ARTICLE 27.3(B)  
5. After summarizing some general points made about  the patent provisions of Article 27.3(b), 
this section summarizes points made with regard to the scope of the exceptions to patentability 
permitted under Article 27.3(b), the ethical excepti ons to patentability permitted under Article 27.2 
and the way in which the conditions of patentability provided for under Article 27.1 apply to plant and 
animal inventions. 
A. G
ENERAL ISSUES  
6. One general issue that h as been discussed is the case for and against providing patent 
protection for plant and animal inventions , especially from a development perspective.  One view 
has favoured a broad provision of patent protecti on for such inventions, for the following reasons: 
- plant and animal inventions, as well as ot her biotechnological inventions, should be 
accorded adequate patent protection, in the same way as inventions in other fields of 
technology, in order to promote private sect or investment in in ventive activities that  IP/C/W/369/Rev.1 
 Page 3 
 
 
  contribute to solving problems in both de veloped and developing countries in areas 
such as agriculture, nutrition, health and the environment;1 
 - for this purpose to be adequately met, it is necessary to have international rules for 
the protection of plant and animal inventions  rather than relying on differing national 
rules;
2 
 - patent protection for plant and animal inve ntions facilitates the transfer of technology 
and the dissemination of  the state-of-the-art research on plant and animal inventions by providing an important incentive for the private sector to conclude licensing 
agreements and by discouraging confid entiality and trade secret arrangements
3 and, 
instead, requiring the publication of patent applications on a global basis;4 
 - patent disclosure requirements and the cont rol over exploitation given to the patent 
owner can facilitate the operation of laws designed to protect public morality, health 
and the environment.
5 
 7. Another view that has been expressed is that patents on life forms give rise to a range of 
concerns, including in regard to development, f ood security, the environment, culture and morality:
6  
These include: 
 - concerns relating to the implications of patent protection in the field of plants for 
access to, and the cost, re-use  and exchange of, seeds, by farmers, as well as 
concerns about the displacement of traditi onal varieties and depletion of biodiversity;7 
  - concerns relating to the grant of excessiv ely broad patents, which do not fully meet 
the tests of patentability and the consequent  problems of "bio-piracy" in respect of 
genetic material and traditi onal knowledge and of the costs and burdens associated 
with the revocation of such patents; 
  - another area of concern has been the vi ew that present international arrangements, 
which it has been said protect the interests of innovators but do no t adequately protect 
the countries and communities that supply the underlying genetic material and 
traditional knowledge, need reba lancing, in particular to make the principles of the 
CBD in regard to prior informed consen t and benefit sharing more effective.  
 8. Some of these points, especially the last two, are elaborated in the Secretariat summary notes 
on the relationship between the TRIPS Agreement and the CBD and the protection of traditional 
knowledge and folklore.   
9. The suggestions that have been made for what action might be taken by the WTO  in regard 
to the patent provisions of Article 27.3(b) in lig ht of the mandated review can be grouped in the 
following categories: 
                                                     
 
1 Japan, IP/C/M/32, para. 142; Switzerland, IP/C/M/30, para. 161 and IP/C/W/284, para. 4; 
United States, IP/C/M/39 para. 114, IP/C/M/42, para. 109; China, IP/C/M/37/Add.1 para. 201. 
2 Singapore, IP/C/M/25, para. 80. 
3 Australia, IP/C/M/24, para. 83. 
4 Australia, IP/C/M/24, para. 83; Canada, IP/C/M/25, para. 91; European Communities, IP/C/M/25, 
para. 72; Japan, IP/C/M/29, para. 150; Switzerland, IP/C/M/30, para. 161. 
5 Switzerland, IP/C/W/284. 
6 India, IP/C/M/25, para. 70, IP/C/M/24, para. 80;  Kenya, IP/C/M/28, para. 143. 
7 Kenya, IP/C/M28, para. 145, IP/C/M/40, para. 106. IP/C/W/369/Rev.1 
Page 4  
 
   - the exceptions to patentability authorized by Article 27.3(b) are unnecessary
8 and 
patent protection should be extended to a ll patentable inventions of plants and 
animals;9  
    - Article 27.3(b) should be maintained as it is,
10 with no lowering of the level of 
protection.11 The provision is well-balanced, preserving Members' rights and 
flexibility to decide whether or not to exclude plants and animals from patentability in the light of their specific national interests and needs.
12  With regard to the process to 
be followed in the review, it has been suggested that this should primarily be one of information sharing on how Members have  implemented Article 27.3(b) nationally;
13 
 
 - retain the exceptions, but provide clarifica tion or definitions of certain terms used in 
Article 27.3(b), especially with a view to clarify the differences between plants, animals and micro-organisms;
14  
 
 - amend or clarify Article 27.3(b) to prohibit the patenting of all life forms, more 
specifically plants and animals, micro-or ganisms and all other living organisms and 
their parts, including genes as well as natural processes that produce plants, animals and other living organisms.
15    It has been argued that the review should provide for 
unqualified exceptions for exclusions from patentability, along the lines of the general and security exceptions in the ot her WTO agreements, that recognize the 
rights of Members to take measures in the public interest, including on ethical and 
moral grounds, and for the introduction of a universal novelty standard in order to 
stop piracy of traditional know ledge and other information.
16 It has also been 
suggested that the Article should be amende d to prohibit the patenting of inventions 
based on traditional knowledge17 or those that violate Article 15 or other provisions 
of the CBD.18  It has been suggested that the obligation of developing countries to 
implement Article 27.3(b) should take effect  five years after the completion of the 
review of this provision.19 
   
                                                     
 
8 United States, IP/C/M/29, para. 185. 
9 Singapore, IP/C/M/29, para. 169; JOB(00)/7853, para. 6. 
10 Australia, IP/C/M/28, para. 152; Canada, IP/C/M/25, para. 91, IP/C/M/40, para. 113; China, 
IP/C/M/37/Add.1, para. 201;  Korea, IP/C/M/26, pa ra. 70; European Communitie s, IP/C/M/43, para. 40. 
11 Japan, IP/C/M/32, para. 142; Singapore, IP/C/M/32, para. 139; IP/C/M/29, para. 169; Switzerland, 
IP/C/M/30, para. 161; European Communities, IP/C/M/43, para. 40.  
12 Brazil, IP/C/M/26, para. 61, IP/C/M36/Add.1, para. 199; Switzerland, IP/C/M/32, para. 123, 
IP/C/M/30, para. 161.  Mexico, IP/C/M/26, para. 76; United States, IP/C/M/37/Add.1, para. 209; Switzerland, 
IP/C/M/40, para. 70; Canada, IP/C/M/40, para. 113; European Communities, IP/C/M/43, para. 40. 
13 Japan, IP/C/M/28, para. 162; Canada, IP/C/M/ 40, para. 111; European Communities, IP/C/M/44, 
para. 42; Australia, IP/C/M/44, para. 44. 
14 Brazil, IP/C/M/30, para. 156 and 183, IP/C/M/25, para. 94; India, IP/C/M/26, para. 55; Peru, 
IP/C/M/29, para. 175; Thailand, IP/C/M/25, pa ra. 78; Zimbabwe, IP/C/M/36/Add.1, para. 201. 
15 India, IP/C/M/29, para. 163, IP/C/W/161; Kenya, IP/C/M/28, para. 146, IP/C/M/40, para. 109; 
Kenya on behalf of the African Group, IP/C/W/163; Zimbabwe, IP/C/M/39, para. 111, IP/C/M/40, para. 75; Bangladesh, IP/C/M/42, para. 103. 
16 Kenya, IP/C/M/28, para. 141, IP/C/M/40, para. 109. 
17 India, IP/C/M/25, para. 70; Kenya, IP/C/M/40, para. 109. 
18 India, IP/C/W/196; Kenya, IP/C/M/40, para. 107. 
19 Kenya on behalf of the African Group, IP/C/W/163.  IP/C/W/369/Rev.1 
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  10. Since 2002  reference has been made to the mandate contained in paragraphs 12 and 19 of the 
Doha Ministerial Declaration.20  This broad mandate has been said to be a more appropriate basis for 
dealing with a wide array of issues raised in the review.21  Reference has also been made to Article 7 
and 8 of the TRIPS Agreement, the development di mension in the Doha Declaration contained in 
paragraph 19 and the objective of su stainable development contained in  paragraph 6 and the recitals 
of the WTO Agreement.22  The link between Article 27.3(b) and development has been said to be the 
central theme of debate in the cont ext of the Doha Development Agenda.23   
11. Concern has more particularly been expressed that  the review of Article 27.3(b) of the TRIPS 
Agreement that started in 1999 has not yet been fina lised.  In order to finalise the review in a manner 
that would reflect a good overall balance for all Members, it has been proposed that areas of possible 
agreement could be identified.  It has been  suggested that these include the recognition: 
(a) of Members’ right and freedom to determin e and adopt appropriate regimes to protect 
plant varieties by an effective sui generis  system, including  non commercial use of 
plant varieties and the system of seed saving and exchange as well as selling among farmers;   
(b) that the TRIPS Agreement and the CBD should be implemented in a mutually 
supportive and consistent manner;   
(c) that the TRIPS Agreement, being a minimu m standards agreement, does not prevent 
Members from protecting traditional knowledge;   
(d) of the importance of documentation of gene tic resources and traditional knowledge to 
help better patent examination.
24   
12. It has also been suggested that in areas where a common understanding did not yet exist, 
further work was needed in the TRIPS Council, including on: 
(a) the proposal to eliminate patent availabilit y for all life forms, including elimination of 
the current TRIPS obligation to patent mi cro-organisms and microbiological and non-
biological processes for the production of plants and animals;25  
(b) recognition of the need to adopt definiti ons to clarify certain terms in Article 
27.3(b);26 
 
                                                      
20 African Group, IP/C/W/404, p.1; Australia, IP/C/M/40, para. 134, IP/C/M/43, para. 44; Brazil, 
IP/C/M/40, para. 132; Canada, IP/C/M/40, para. 133;  China, IP/C/M/43, para. 56; European Communities, 
IP/C/W/383, para. 1;  India IP/C/M/40, para. 83, 129; Malaysia, IP/C/M/43, para. 40; New Zealand, IP/C/M/43, 
para. 45; Switzerland, IP/C/M/40, para. 69, IP/C/W/400 /Rev.1, para.1; United States, IP/C/M/40, para. 131; 
Zimbabwe, IP/C/M/36/Add. 1, para. 200, IP/C/M/39, para. 111,112, IP/C/M/40, para. 80; China, Colombia, 
Cuba, Dominican Republic, Kenya, Peru, Venezuela, IP/C /M/40, para. 135; European Communities, IP/C/M/44 
para. 28.  
21 European Communities, IP/C/W/383, para. 4.  
22 European Communities, IP/C/W/383, para. 3;  Kenya, IP/C/M/40, para. 106; Zimbabwe, 
IP/C/M/36/Add.1, para. 200, IP/C/M/39, para. 112. 
23 European Communities, IP/C/W/383, para. 13. 
24African Group, IP/C/W/404, p. 2; Zimbabwe, IP/C/M/36/Add.1, para. 201. 
25 African Group, IP/C/W/404, p. 3. 
26 Zimbabwe, IP/C/M/37/Add.1, para. 197. IP/C/W/369/Rev.1 
Page 6  
 
  (c) the protection of traditional knowledge;
27  and 
(d) the way to make the TRIPS Agreemen t and the CBD mutually supportive.28 
13. As a way of moving forward it has been propo sed that, where the views of delegations 
suggest a common understanding, the Council for TR IPS should agree upon a Decision and report the 
adoption of the Decision to the TNC.  The Decisi on should become operational immediately.  It has 
been stated that such a Decision would have to be  worthwhile in terms of adequately addressing most 
of the issues that have arisen in the review so  far, and further it would have to contain a clear 
commitment to continue the review and finalise it within an agreed time fra me.  For those areas where 
there is no common understanding, the Council for TRI PS should continue its work, but should do so 
within a specific timeframe that addresses the grave concerns of Members on the slow progress with 
the work programme.29   
14. In response to this proposal, it has been sai d that Article 27.3(b) provided considerable 
flexibility for WTO Members since individual Member s were free to exclude from patentability plants 
and animals and essentially biological processes for the production of plants and animals.30  By the 
same token, Members were free to provide patent protection for such subject-matter which some had 
used to develop a strong biotechnology industry.31  It has been said that the subject under discussion is 
evolving and account needs to be taken of devel opments in the field of biotechnology during the 
review of Article 27.3 (b)32.  The need to identify specific dema nds and to present comprehensive and 
concrete proposals on the issues under discussion, as a basis for focused and structured discussions, 
has also been raised.33  
15. Developing country Members and those from c ountries in transition to a market economy, 
which had not already done so, were urged to res pond to the Secretariat's illustrative list of questions34 
and submit information to the TRIPS Council on the manner in which they implement the provisions 
of Article 27.3(b).35  This would enable the Council to conduc t the review under Article 27.3(b) on the 
basis of Members' experiences with implementing the provisions related to patents on life forms and sui generis  protection of plant varieties.
36 
16. The more specific suggestions made regard ing the relation between the Convention on 
Biological Diversity (CBD) and the protection of trad itional knowledge and folklo re are dealt with in 
the Secretariat summary notes on those two matters (IP/C/W/368/Rev.1, IP/C/W/368/Rev.1./Corr.1) and (IP/C/W/370/Rev.1). 
                                                     
 
27 African Group, IP/C/W/404, p. 4. 
28 African Group, IP/C/W/404, p. 5. 
29 African Group, IP/C/W/404, p.6;  Zimbabwe, IP/C/M/36/Add. 1, paras. 200-201, IP/C/M/40, paras. 
74-80. 
30 Canada, IP/C/M/40, para. 113;  Switzerland, IP/ C/ M/40, para. 70;  United States, IP/C/M/37 Add.1, 
para. 209; European Communities, IP/C/M/43, para.  40. 
31 United States, IP/C/M/37/Add.1, para. 209. 
32 Singapore, IP/C/M/37/Add.1, para. 218. 
33 European Communities, IP/C/W/383, para. 8, IP/C/M/44, para. 28.  
34 Chairperson, IP/C/M/28, para. 173, IP/C/M/30, para. 186; IP/C/M/32, para. 122;  Canada, 
IP/C/M/40, para. 111, 113. The Secretariat's illustrative lis t of questions is contained in IP/C/W/273 and Rev.1. 
The responses by Members to these questions are listed in List D of the Annex to this document. 
35 United States, IP/C/M/39, para 113. 
36 Canada, IP/C/M/40, para. 111, 113.    IP/C/W/369/Rev.1 
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  B. SCOPE OF EXCEPTIONS TO PATENTABILITY IN ARTICLE 27.3( B) 
17. Issues have been raised regarding th e scope of the exceptions, including the definition of the 
terms used, in Article 27.3(b).  It has been argued th at the absence of clear definitions could pose 
problems of legal uncertainty as regards the scope of patentability under Article 27.3(b),37 and that it 
is necessary to define the terms at bot h the national and international level.38  The difficulty to get 
WTO Members to agree on definitions should no t deter the Council from developing precise 
definitions of certain terms.39   
18. In response, the view has been expressed that it is difficult to get all WTO members to agree 
on definitions as decisions are ma de by consensus and the issues involved are complex.  Doubt has 
been expressed whether the TRIPS Council should stud y and clarify the issue of micro-organisms, as, 
in case of a dispute, this would hand the interpreta tion of these definitions to the DSB, including the 
Appellate Body, and this would not be desirable.40  It has further been argued that the absence of 
definitions at the international level affords Memb ers flexibility in the use and interpretation of these 
terms,41 whereas a clear definition of the term micro-or ganism is important at the national level, as 
this is the only form of living organisms for whic h Members are obliged to provide patent protection 
and which are widely used in the pharmaceu tical, chemical and biotechnology industries.42 It has also 
been said that the more important issue with respect to micro-organisms is whether or not the patentability criteria are met.
43  The view has also been expressed  that the term "review" does not 
mean that WTO Members are under a duty to agr ee on an exhaustive definition of each and every 
term, but rather to see how different Members define and apply these terms.44 
19. Regarding the question whether WIPO or the WTO is the right forum to discuss such 
definitions, it has been questioned whether the TRIPS Agreement could or should go into this amount 
of detail.45  It has been stated that WIPO rather than the TRIPS Council is the right forum to agree on 
technical definitions, as they have more expertise.46  In response, it has been pointed out that the WTO 
membership is more or less replicated in WIPO, a nd that with regard to technical expertise the WTO 
can enlist the services of experts at WIPO  to arrive at specific definitions.47  It has also been said that 
there is no intention on the part of Members advoc ating precise definitions to diminish or erode any 
flexibilities that Members have in resp ect of the meanings that they currently attribute to any of those 
terms,48 as such flexibilities also provide protection ag ainst unilateral pressure to take on higher 
commitments than those in the TRIPS Agreement.49  However, specific meanings could be agreed 
upon while preserving reasonable flexibilities.50 
                                                      
37 Brazil, IP/C/M/29 para. 146; Pakistan, IP/C/M/25 para. 88., Kenya, IP/C/M/28 para. 141-146;  
Mauritius on behalf of the African Group, IP/C/W/206; Zimbabwe, IP/C/M/36/Add.1 para. 201. 
38 Zimbabwe, IP/C/M/37/Add.1, para. 198. 
39 Zimbabwe, IP/C/M/37/Add.1, para. 197. 
40 Peru, IP/C/M/37/Add.1, para. 217. 
41 European Communities, IP/C/W/383, para. 20. 
42 European Communities, IP/C/W/383, para. 21. 
43 European Communities, IP/C/W/383, para. 21.  
44 European Communities, IP/C/W/383, para. 24.  
45 European Communities, IP/C/W/383, para. 18; United States, IP/C/M/37/Add.1, para. 210. 
46 European Communities, IP/C/M/37/Add.1, para. 200, IP/C/W/383, para. 19;  United States, 
IP/C/M/37/Add.1, para. 210. 
47Peru, IP/C/M/37/Add.1, para 217,  Zimbabwe, IP/C/M/37/Add.1, para. 199. 
48 Zimbabwe, IP/C/M/37/Add.1, para. 199. 
49 Peru, IP/C/M/37/Add.1, para. 217. 
50 Zimbabwe, IP/C/M/37/Add.1, para. 199. IP/C/W/369/Rev.1 
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  20. In regard to the definition of plants and animals , it has been suggested that it should be 
made clear that parts of plants and animals are excludable from patentable subject-matter.
51  I n  
particular, it has been said that there are ambiguities about the meaning of "plants",52 and that cells, 
cell lines, genes and genomes should be excluded.53 
21. With regard to micro-organisms , the view has been expressed that there is no scientific or 
other rationale for distinguishing between plants and animals on the one ha nd and micro-organisms on 
the other.  Both should not be patentable, since both are living things which can only be discovered 
and not invented.54  The view has also been expressed that there is no consensus on the meaning of the 
term "micro-organism" in the scientific community.55  For example, it has been argued that the 
scientific definition of micro-organisms only comp rises bacteria, fungi, algae, protozoa and viruses56 
and it has been questioned whether biological materi al such as cell lines, enzymes, plasmids, cosmids 
and genes should qualify as micro-organisms.57  It has also been said that  there is no scientific basis 
for the distinction between plants, animals and micro-organisms.58 
22. In response, the view has been expressed that the distinctions ma de in Article 27.3(b) are in 
accordance with the generally accepted scientific classification of organisms59 and that the notion of 
categorising life-forms into plants, animals and micro-organisms is widely accepted in existing 
international agreements, including the CBD.60  It has been said that the absence of a definition in the 
TRIPS Agreement of the term "micro-organism" reflects  the fact that the term has not been defined by 
patent experts anywhere, not even in the Budap est Treaty on the International Recognition of the 
Deposit of Micro-organisms for the Purposes of Patent  Procedures.  It has also been said that the 
WIPO Committee of Experts on Biotechnological I nventions and Industria l Property, which met 
between 1984 and 1988, did not define the term "micro-organism", although the term was used 
frequently in its discussions.  It has been said that th e reason for the lack of a definition is reflected in 
the Comparative Study of Patent Practices in the Field of Biotechnology Related Mainly to 
Microbiological Inventions , dated 20 January 1988, prepared jointly by the European Patent Office, 
the Japanese Patent Office and the US Patent and Trademark Office.  Page 3 of that document 
contains the following text, under the heading "Definition of Micro-organism, If Any": 
"None of the laws administered by any of the Offices contains a formal definition of 
the term 'micro-organism'.  Where defin itions are used in either classification 
definitions or administrative guidelines, the term is defined as a non-exclusive list of 
organisms which are included within the scope of that term.  As noted by the EPO, it 
does not seem expedient to introduce such a definition as the rapid evolution in the 
field of microbiology would n ecessitate its frequent updating." 
Thus, it has been argued, patent experts have reco gnized that any definition that would be agreed 
upon today would have to be update d later due to the rapid evolution of research in this field.61  It has 
been said that, if patent officials operating in more  technically expert forums have not considered it 
                                                      
51 India, IP/C/W/161. 
52 Kenya, IP/C/M/42, para.120. 
53 Kenya, IP/C/M/28 para. 152; Zimbabwe, IP/C/M/39 para. 111. 
54 Kenya on behalf of the African Group, IP/C/W/163. 
55 Brazil, IP/C/M/29, para. 146; Japan, IP/C/W/2 36; Switzerland, IP/C/W/284; Venezuela, IP/C/M/29 
para. 199.  
56 Zimbabwe, IP/C/M/39, para. 111. 
57 India, IP/C/M/25, para. 70, IP/C/W/ 161; Pakistan, IP/C/M/26, para. 65.  
58 Kenya on behalf of the African Group, IP/C/W/163. 
59 Switzerland, IP/C/W/284. 
60 Japan, IP/C/M/29, para. 151. 
61 United States, IP/C/M/28, para. 131, IP/C/M/35, para. 222, IP/CM/37/Add.1, para. 210; Singapore, 
IP/C/M/37/Add.1, para. 218.  IP/C/W/369/Rev.1 
 Page 9 
 
 
  appropriate to define the term "micro-organism", it would not be wise for the TRIPS Council to 
attempt such a task.  23. The question of how WTO Members and, if necessary, a WTO panel should interpret the term 
"micro-organism" given the absence of a definition has been discussed.  One vi ew has been that the 
principles of international law regarding the interpre tation of treaties, in particular Articles 31 and 32 
of the Vienna Convention on the Law of Treaties, should be used.
62  The Vienna Convention provides 
that the basic rule of interpretation is the ordinary meaning of terms in their context and in the light of 
the agreement's object and purpose.  In this regard, it has been said that the dictionary meaning should 
suffice for distinguishing plants and animals from micro-organisms for the purposes of the TRIPS 
Council.63  The Concise Oxford Dictionary defines the ordinary meaning of "micro-organism" as "an 
organism not visible to the naked eye, e.g., bacterium or virus". 
24. In response, it has been said that, in interpre ting the term "micro-organism", Article 31(4) of 
the Vienna Convention on the Law of Treaties is more relevant, namely the negotiating history of 
Article 27.3(b).  In this regard, it has been said th at negotiators of the TRIPS Agreement questioned, 
but did not investigate, whether patents would ex tend to cell-lines, enzymes, plasmids, cosmids and 
genes and therefore the Agreement contained te rms on the meaning of which agreement was not 
reached.64  It has also been said that a dictionary refe rence is not very helpful for dealing with the 
several "borderline" categories of life-forms that c ould be classified as either micro-organisms or as 
plants and animals.  Moreover, the view has been  expressed that the term is obviously intended to 
have a special meaning in the context of patentabilit y and the dictionary explanation and example of a 
bacterium or virus do not necessarily concern patentable micro-organisms.65 
25. With regard to what action should be taken in  the WTO on the treatment of micro-organisms, 
the following views have been expressed: 
 - micro-organisms, like other biological and living organisms, should be excluded from 
patentability.66 In the event that living organi sms remain patentable, a provision 
should be incorporated into the TRIPS Agreement to the effect that patents must not 
be granted without the prior consent of the country of origin in order to affirm its 
compatibility with the CBD and the Intern ational Treaty on Plant Genetic Resources 
for Food and Agriculture (ITPGRFA);67 
  - the coverage of the term "micro-organisms" should be clarified, in particular so as to 
exclude cell-lines, enzymes, plasmids, cosmids and genes;
68 
  - individual Members should determine and apply the term in their national 
jurisdictions in accordance with Ar ticle 1.1 of the Budapest Treaty
69 and not seek to 
define the term.  Patent experts have a fairly clear idea of the term but the issue is 
complex and therefore it is better left to each Member's patent offices and experts to 
determine;70 
                                                      
62 United States, IP/C/W/209. 
63 Japan, IP/C/M/29, para. 151; Korea, IP/C/M/32, para. 140; Switzerland, IP/C/M/30, para. 163, 
IP/C/W/284; United States, IP/C/M/35, para. 222, IP/C/M/28, para. 131, IP/C/W/209. 
64 India, IP/C/M/25, para. 70. 
65 Brazil, IP/C/M/29, para. 146; India, IP/C/M/30, para. 168. 
66 Kenya, IP/C/M/28, para. 152; Bangladesh, IP/C/M/42, para. 103. 
67 Bangladesh, IP/C/M/42, para. 103. 
68 Kenya, IP/C/M/28, para. 152. 
69 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes 
of Patent Procedure and Regulations, done at Budapest on 28 April 1977 and amended on 26 September 1980. 
70 Korea, IP/C/M/35, para. 225. IP/C/W/369/Rev.1 
Page 10  
 
   
 - it should be left to national policy to d ecide what are patentable micro-organisms;
71 
  - it has also been said that it is important to consider what approach has been taken in 
each Member's legal framework and that such a flow of information would be useful 
for a collective understanding of the natu re of the terms under discussion and for 
clearing up concerns or grey areas.
72 
 
26. With regard to non-biological and micro-biological processes , concern has been expressed 
that Article 27.3(b) incorporates specific obligati ons on the patenting of such processes but does not 
define these terms.73  It has been suggested that artificial distinctions between essentially biological 
processes on the one hand and microbiological and n on-biological processes on the other hand should 
be removed74 or clarified.75  The view has been expressed th at micro-biological processes are 
biological processes and should be treated in the same manner as other biological processes in the TRIPS Agreement.
76   
C. ETHICAL EXCEPTIONS TO PATENTABILITY AND ARTICLE 27.2 
27. It has been said that the criteria and rationa le for what could and could not be excluded from 
patentability on the grounds that inventions are contrary to ordre public  or morality, including on 
grounds of protection of life and health of human s, animals and plants, should be examined in the 
review given the direct link to Article 27.3(b).77  It has been suggested that the following specific 
concerns should be taken into acc ount:  those relating to public h ealth, restrictions on research 
materials78, limitations on competition as in the case of gene use restriction technologies (GURTs),79 
human rights, agricultural security, bio-piracy, traditional knowledge and farmers' rights80 and the 
concern that the current provisions of Article 27.3(b) did not prevent the abuse of patent systems.81  
28. The view has been expressed that patenting of life forms is in itself unethical and harmful and 
therefore should be unconditionally prohibited.  Artic le 27.2 is not sufficient for this purpose as the 
conditions it imposes on action to protect ordre public or morality are unnecessary and cumbersome,82 
for instance that the commercial exploitation of the invention must also be prevented.83  The 
qualifications included in Article 27.2 am ount to redefining morality for Members.84 The view has 
also been expressed that patents on life forms ma ke the exceptions in Article 27.2 for protecting ordre 
                                                      
71 India, IP/C/W/161.  
72 Australia, IP/C/M/29, para. 190;  United States, IP/C/M/39, para. 113;  Canada, IP/C/M/40, 
para. 111. 
73 India, IP/C/M/24, para. 8. 
74 Kenya, , IP/C/M/28, para. 146. 
75 Brazil, IP/C/M/29, para. 146; Zimbabwe, IP/C/M/39, para. 111. 
76 Kenya, on behalf of the African Group, IP/C/W/163; Zimbabwe, IP/C/M/39, para. 111. 
77 Australia, IP/C/M/28, para. 152; Brazil, IP/C/W /228; Ecuador, IP/C/M/30, para. 184, IP/C/M/25 
para. 87; India, IP/C/M/28, para. 127, IP/C/M/25, para. 70; Kenya, IP/C/M/28, para. 143, IP/C/M/40, para. 109; Mauritius on behalf of the African Group IP/C/W/206; Norway, IP/C/M/25, para. 76; Pakistan, IP/C/M/24, 
para. 86; South Africa, IP/C/M/25, para. 79. 
78 Kenya, IP/C/M/28, para. 141; Mauritius on behalf  of the African Group, IP/C/W/206; Zimbabwe, 
IP/C/M/39, para. 112.  
79  India, IP/C/M/28, para. 126. 
80 Brazil, IP/C/W/228. 
81 Zimbabwe, IP/C/M/39, para. 112.   
 82 Kenya, IP/C/M/28, para. 143, IP/CM/40, para. 105; Zimbabwe on behalf of the African Group, 
IP/C/M/40, para. 75. 
83 India, IP/C/W/161. 
84 Kenya IP/C/M/28, para. 143, IP/CM/40 para. 105.  IP/C/W/369/Rev.1 
 Page 11 
 
 
  public  and morality meaningless for those Members that consider patents on life forms to be immoral, 
contrary to the fabric of their society and culture  and would want to invoke these exceptions in this 
regard.85  The minimum that was acceptable in this rega rd is to clarify that paragraph 3 does not in 
any manner restrict the rights of Members to  resort to the exceptions in paragraph 2.86  
29. It has been said that ethical and moral matters  are not matters for commercial calculations and 
their force should not be affected by reasoned commercial concerns.87  Cultural and social values of 
many societies cannot countenance the appropriation or marketing of life in any form or at any stage. 
The preponderance of such inherent values in partic ular countries is a matter for democratic domestic 
legislative process to determine and not for the WT O whose trade mandate is narrow and insufficient 
to decide on these matters.88 
30. In response, the view has been expressed th at Article 27.2 adequately takes into account 
ethical concerns as far as patent law is concerned and that other ethical issues have to be addressed 
and dealt with in other laws, such as on the protec tion of the environment, public health or animal 
welfare.89  In this regard, the point has been made that patents do not guarantee the patent holder 
unfettered exploitation of the patented invention.  Such exploitation is subject to the national law of 
the Member in question, including on matters of et hics, animal welfare, bio-safety etc.  A Member 
might legitimately enforce its national law to proh ibit patentees from exploiting patented inventions 
for various reasons, including ethical ones.  There is  no need to exclude inventions from patentability 
in order to prevent their exploitation.90  Moral and ethical concerns relating to the research into life-
forms and the exploitation of the results of that rese arch are better legislated on directly rather than 
through patent laws.91  It has been said that, in fact, excluding particular subject-matter from 
patentability will not in itself prevent either research or exploitation of such technology.92  Instead, it 
could make it more difficult to control, for example by encouraging secrecy.93  It has also been said 
that discussion on this issue is difficult because the moral and ethical concerns expressed by some 
Members about patenting life forms have not been specified.94 
31. In response, it has been said that, while it may be possible to restrict undesirable research by 
other means, it has to be taken into account that  patents have an incentive effect on research and 
development.  Therefore, restriction of the grant of intellectual property rights can be a tool to 
discourage research contrary to ethical, cultural or religious standards.95 
32. The view has also been expressed that Article 27.3(b) already allows Members considerable 
freedom with regard to the patentability of biot echnological inventions and that it is up to each 
Member to strike the right balance taking into account economic, ethical and other concerns, without 
losing sight of the fact that granting intellectual pr operty rights to biotechnology inventions is one of 
the factors for developing domestic skill in this sector.96   Further it has been said that it should be 
                                                      
85 African Group, IP/C/W/404, p. 2; Zimbabwe, IP/C/M/39, para. 115.  
86 African Group, IP/C/W/404, p.4. 
87 Kenya, IP/C/M/40, para 105. 
88 Kenya, IP/C/M/40, para 105. 
89 European Communities, IP/C/M/25, para. 73; Japan, IP/C/W/236; Switzerland, IP/C/M/30, 
para. 162, IP/C/W/284; United States, IP/C/M/30, para. 176. 
90 Japan, IP/C/M/29, para. 153. 
91 United States, IP/C/W/162. 
92 United States, IP/C/W/209.  
93 Switzerland, IP/C/W/284. 
94 United States, IP/C/W/162.  
95 Brazil, IP/C/W/228. 
96 European Communities, IP/C/W/383, para. 27, IP /C/M/43, para. 40; United States, IP/C/M/39, 
para. 113. IP/C/W/369/Rev.1 
Page 12  
 
  remembered that Article 27.3 (b) is the result of a carefully negotiated balance.
97  The view has also 
been expressed that biological materials are resear ch ingredients and that patents for these materials 
should be granted as long as the patentability require ments are met and the commercial exploitation of 
such living organisms does not go against public order.98 
D. CONDITIONS OF PATENTABILITY IN ARTICLE 27.1  AND  PLANT AND ANIMAL INVENTIONS  
33. The way in which the basic crite ria for patentability set out in Article 27.1, namely novelty, 
inventive step (or non-obviousness) and industrial a pplicability (or usefulness), should be applied in 
the case of micro-organisms and micro-biological processes and other plant and animal inventions that may be patentable under national law has been  discussed.  In this regard, the view has been 
expressed that the lack of clear definitions of the conditions for patentability has left grey areas, in 
particular with respect to the definition of the te rm "invention" and the sc ope of patentable micro-
organisms and microbiological or non-biological processes.
99  Leaving the issue purely to the 
discretion of Members could give rise to a number of concerns.100 
34. Another view is that it should be left up to the domestic laws and practices of the national 
patent offices to define these matters.101  That freedom constitutes part of the flexibilities in the TRIPS 
Agreement.102   
35. One issue raised has been the use of unduly low thresholds for novelty, inventive step and 
industrial applicability .  It has been said that the lax criteria applied by some Members is 
undermining the patent system as a whole.103  Concern has been expressed that some patent offices 
either do not have appropriate procedures or reward  their examiners on the basis of the number of 
patent applications handled, ther eby encouraging examiners to be less than careful in granting 
patents.104  In this context it has been said that ove r-broad patents can restrict access to genetic 
material and restrict or raise the cost of research, thus giving rise to questions of compatibility with 
the CBD.105 
36. The issue of the distinction to be made between discoveries and inventions , and, in 
particular, what is required to satisfy the test of inventive step  (or non-obviousness) has been raised.  
It has been said that, by stipulating the patenting of micro-organisms and micro-biological processes, 
the TRIPS Agreement violates the basic tenet of pate nt law that,  while discoveries are not patentable, 
inventions are.106  It has also been said that  there is need for a clearer understanding of which stages of 
research into genetic resources, including genetic pa rts and components, constitute "discoveries" and 
which ones fulfil the requirements of being an invention.107  A specific point that has been made in 
this connection relates to the patenting of  genetic materials in their natural state.108  It has been argued 
that some Members define inventions to include di scovery of naturally occurring matter, or the mere 
                                                      
97 Canada, IP/C/M/40, para. 112. 
98 China, IP/C/M/37/Add.1, para. 201. 
99 India,IP/C/W/161; IP/C/M/28, para. 128. 
100 India, IP/C/M/28, para. 126. 
101 Venezuela, IP/C/M/29, para. 199. 
102 European Communities, IP/C/M/43, para.40; Unite d States, IP/C/M/37/Add.1, para. 209, IP/C/M/39 
para. 113. 
103 Brazil, IP/C/W/228. 
104 Brazil, IP/C/M/29, para. 146, IP/C/W /228; India, IP/C/M/28, para. 126. 
105 Brazil, IP/C/M/25, para. 94, IP/C/W/228.  
106 Kenya on behalf of the African Group, IP/C/W /163¸ Mauritius on behalf of the African Group, 
IP/C/W/206; Zimbabwe, IP/C/M/39, para. 112. 
107 Malaysia, IP/C/M/32, para. 143; Cuba, IP/C/M/40, para. 118. 
108 Brazil, IP/C/M/29, para. 146; India, IP/C/M/25, para. 70; Kenya, IP/C/M/28, para. 141; Kenya on 
behalf of the African Group, IP/C/W/163; Peru, IP/C/M/29, para. 175; Zimbabwe, IP/C/M/39, para. 112.  IP/C/W/369/Rev.1 
 Page 13 
 
 
  isolation of such matter, and that this has led to  patents on life forms found in their natural state and 
on research materials.109.  It has been questioned whether the mere  act of isolation of genetic material 
from its natural state would satisfy the test  of non-obviousness or of the inventive step.110  The view 
has been expressed that the negotia ting history of the TRIPS Agreement shows that the negotiators 
were not able to agree that the task of isola ting a bacterium would satisfy the inventiveness test.111 It 
has also been said that, however costly it may be to day to isolate a micro-organism, in many instances 
it may correspond better to a mere di scovery than to an invention. 112  Members should be able to limit 
the grant of patents in respect of micro-organisms to  those that had been transgenetically modified and 
satisfy the requirements of patentability.113 
37. In response, it has been said that mere discove ries, not involving human intervention, are not 
considered patentable subject-matter. 114  Examples have been given to illustrate the point, relating to 
ores, natural phenomena, chemical substances or mi cro-organisms found in nature.  Life-forms in 
their natural state would not satisfy the criteria for patentability in the TRIPS Agreement.115   It has 
been elaborated that if, however, naturally occu rring things, such as chemical substances or micro-
organisms, have been first isolated artificially fro m their surroundings in nature they are capable of 
constituting an invention.  It has also been said that the subject-matter of a patent has involved 
sufficient human intervention, such as isolation or pur ification, and if the isolated or purified subject-
matter is not of a previously recognized exis tence, then it is considered an invention.116  P l a n t s ,  
animals or micro-organisms and other genetic resour ces would have to be altered by the hand of man 
or produced by means of a technical pro cess to satisfy the criteria of patentability.117    
38. In regard to novelty,  it has been argued that universal novelty should be introduced in order to 
deal with piracy of traditional knowledge.118  It has been said that some members define novelty in a 
manner that does not recognize information available to the public through the use of oral traditions 
outside their domestic jurisdictions.119  This point is more fully discu ssed in the Secretariat's summary 
note on the protection of traditional knowledge and folk lore.  In regard to the patent obligations on 
micro-organisms in the TRIPS Agreement the point h as been made that the mere fact that a micro-
organism or a gene has existed in nature does not  mean that it has become known to the public and 
ceases to be "new" for patent purposes.120   
39. It has been questioned whether some patents claimed over micro-organisms adequately fulfil 
the requirements of industrial applicability  as the usefulness of the inventions is often unclear even 
                                                      
109 Kenya, IP/C/M/28, para. 141. 
110 India, IP/C/M/29, para. 161; Zimbabwe, IP/C/M/39 para. 112. 
111 India, IP/C/M/29, para. 161. 
112 Brazil, IP/C/W/228. 
113 Brazil, IP/C/W/228. 
114 Japan IP/C/M/29, para. 151, IP/C/W/236; Switzerland, IP/C/M/30, para. 164. 
115 Japan, IP/C/M/29, para. 151; Switzerland, IP/C /M/30, para.164; United States, IP/C/M/28, para. 
131, IP/C/M/25, para. 71, IP/C/W/209. 
116 Australia, IP/C/M/24, para. 83; European Communities, IP/C/W/254; Japan, IP/C/M/29, para. 151, 
IP/C/W/236; Malaysia, IP/C/M/30, para. 179; Switzer land, IP/C/M/30, para. 164; United States, IP/C/M/29 
para. 186. 
117European Communities, IP/C/W/254; Japan, IP /C/M/29, para. 151, IP/C/W/236; Switzerland, 
IP/C/M/30, para. 164; United States, IP/C/M/29, para . 186; United States, IP/C/M/37/Add.1, para. 209. 
118 Kenya, IP/C/M/40, para. 109. 
119 India, IP/C/M/28, para. 126; Kenya, IP/C/M/28, para. 141; Zimbabwe, IP/C/M/39, para. 112. 
120 Japan, IP/C/W/236. IP/C/W/369/Rev.1 
Page 14  
 
  to the patent applicant.
121  It has also been said that with respect to gene sequences some Members 
require the description of a function while others do not.122   
40. A general point made in relation to the above concerns has been that, if the criteria for 
patentability have not been properly applied, the patent system provides for opposition and revocation 
procedures to remedy such situations.123  In response, concerns have been expressed about the 
financial and other resource costs and delays involved  in keeping track of such patents and using such 
procedures, especially where pre-grant opposition is not possible.124 
41. There has been some discussion on the patenting of genes  and, more specifically, DNA 
sequences.  It has also been said that there a ppeared to be a number of different views among 
Members on the granting of patents in regard to DNA sequences125:  it is sufficient to discover a 
certain sequence of the DNA;  it is necessary also  to describe the function of the DNA sequence;  a 
distinct diagnostic and therapeutic application sh ould also be identified for the particular DNA 
sequence.  In the discussion, it has been said that a gene, if isolated and purified from the originating 
biological material, should be considered to be an  invention as it is a particular kind of chemical 
substance.  This is because micro- organisms and genes could be charact erised in the patent claims by 
their structure, by parameters or by other appropriate means.126  In response it has been said that, 
while in some cases the biological material is also a chemical, as in the case of artificial enzymes, and 
hence could be patentable as a chemical, the TRIPS Agreement does not require genes to be 
patentable, since they are parts of living organisms,  except if they also qualify as a micro-organism 
that is patentable under the national law.127   
42. The role of the correct application of patentab ility criteria, organized databases and effective 
post-grant opposition procedures in preventing erroneous ly granted patents has also been discussed in 
the context of the relationship between TRIPS and the CBD and in the context of the protection of 
traditional knowledge and folklore. The point is therefore discussed in more detail in the two 
summary notes on these topics (IP/C/W/368/Rev.1, IP/C/W/368/Rev.1/Corr.1) and (IP/C/W/370/Rev.1). 
III. ISSUES RELATING TO THE SUI GENERIS  PROTECTION OF PLANT VARIETIES 
43. This section is concerned with the issues that have  been raised and points made with regard to 
the provision of Article 27.3(b) relating to the sui generis  protection of plant varieties.  After 
summarizing points made on some general issues, the section then describes the views that have been 
expressed about:  first, what are the elements of an effective sui generis  system;  second, the 
relationship between the TRIPS provision and the International Union for the Protection of New 
Varieties of Plants (UPOV) Convention, and, thir d, the relationship with traditional knowledge and 
farmers' rights.  
A. G
ENERAL ISSUES WITH RESPECT TO PLANT VARIETY PROTECTION  
44. This sub-section deals with the general issues raised in the discussion on the protection of 
plant varieties including whether or not such prot ection should be accorded and whether or not the 
provisions contained in Article 27.3(b) are balanced or need to be amended. 
                                                      
121 Brazil, IP/C/W/228; Zimbabwe, IP/C/M/39, para. 112. 
122 Pakistan, IP/C/M/26, para. 64. 
123 Switzerland, IP/C/M/30, para. 164. 
124 India, IP/C/W/161. 
125 Pakistan, IP/C/M/26, para. 64. 
126 Japan, IP/C/M/29, para. 151, IP/C/W/236.  
127 India, IP/C/W/161.  IP/C/W/369/Rev.1 
 Page 15 
 
 
  45. With regard to the question of why plant varieties should be protected , the point has been 
made that such protection allows development of new technological solutions in the field of 
agriculture.128  It encourages the easy introduction of new varieties and ensures that breeders continue 
breeding effectively.129  More particularly, the point has been  made that improvements in agricultural 
biotechnology have resulted in the design of new pl ants through direct manipulation of the genome of 
a plant rather than reliance upon conventional plant breeding techniques that involve a trial and error 
process.  Advances in the area include the devel opment of new crops with higher productivity and 
yields and with disease resistance.130  Further, it has been said that strengthening plant varieties 
protection ensures a  more efficient agricultural sector.131 
46. On the other hand, concerns have been expressed  that the protection of plant varieties can 
have an adverse impact upon the fulfilment of the na tional goals of developing countries, in particular 
in regard to food security, health, rural deve lopment and equity for local communities whose 
traditional knowledge systems have produced staple va rieties, including varieties that have medicinal 
and biodiversity value.132  It has been suggested that plant va riety protection could lead to excessive 
dependence on foreign commercial br eeders, and that such persons could not always be relied upon.133 
Concern has also been expressed about the possi ble adverse implications for the cooperative 
relationships among neighbouring farmers that are co mmon in developing countries and the difficulty 
of traditional farmers in having the capacity or educ ation required to use the system to protect their 
own interests.134  The view has further been expressed th at although the TRIPS Agreement is not to 
apply to least-developed countries until 2006,135 and 2016 with respect to pharmaceutical products, 
the imposition of patenting requirements on some least-developed countries is imminent through 
bilateral arrangements.136 
47. With respect to the question as to whether provi sions in the TRIPS Agreement relating to the 
protection of plant varieties strike the right balance  between right holders and other interests  that 
are involved, two views have been expressed: 
 - Article 27.3(b) provides a certain degree of flexibility to Members in deciding on the 
most effective means of sui generis  protection for plant varieties and that the status 
quo should be maintained; 137 
  - while preserving the flexibility in Article 27. 3(b), clarification of the term "effective 
sui generis  system" is needed
138 and Members should confirm and lock in, by way of 
a decision, a common understanding that Members have the right and freedom to 
determine and adopt appropriate regimes.139  Members should also confirm a 
                                                      
128 Japan, IP/C/M/29, para. 152, IP/C/M/40, para. 98; United States, IP/C/W/162. 
129 Japan, IP/C/M/40, para.98. 
130 Japan, IP/C/M/29, para. 152, IP/C/M/40, para. 98; United States, IP/C/W/162. 
131 Norway, IP/C/M/43, para. 52. 
132 Mauritius on behalf of the African Group, IP/C/W/206; Peru, IP/C/M/29, para. 175; Zimbabwe, 
IP/C/M/36/Add.1, para. 201; Kenya, IP/C/M/40, para. 108. 
133 Kenya, IP/C/M/28, para. 145. 
134 India, IP/C/M/28, para. 125. 
135 On 29 November 2005, the Council for TRIPS extended the transition period under Article 66.1 for 
least-developed country Members until 1 July 2013 (IP/C/40). 
136 Bangladesh, on behalf of LDCs, IP/C/M/42, para. 102. 
137 Brazil, IP/C/M/29, para. 147; European Commun ities, IP/C/M/35, para. 214; Egypt, IP/C/M/25, 
para. 92; Malaysia, IP/C/M/29, para. 206; Mexico, IP/C/M/ 26, para. 76; Peru, IP/C/M/29, para. 175; Venezuela, 
IP/C/M/29, para. 200; Thailand, IP/C/M/42, para. 115. 
138 Brazil IP/C/W/228; India, IP/C/M/25, para. 70;  Kenya, IP/C/M/28, para. 146, Kenya on behalf of 
the African Group, IP/W/163; Thailand, IP/C/M/25, pa ra. 78;  European Communities, IP/C/M/35, para. 214.   
139African Group, IP/C/W/404, p.2; Zimbabwe, on behalf of the African Group, IP/C/M/40, para.79. IP/C/W/369/Rev.1 
Page 16  
 
  common understanding that regardless of what sui generis  system is adopted for 
protecting plant varieties, non-commercial use of plant varieties, the system of seed 
saving and exchange as well as the selling among farmers, are rights and exceptions that should be ensured as matters of impor tant public policy to, among other things, 
ensure food security and preserve the in tegrity of rural or local communities.
140 
 
48. Specific suggestions for possible clarifications that have been made are: 
 - reference could be made to th e UPOV Convention in Article 27.3(b);141 
  - a footnote should be inserted after th e sentence on plant variety protection in 
Article 27.3(b), stating that any sui generis  law for plant variety protection can 
provide for:  (i) the protection of innova tions of indigenous and local farming 
communities in developing countries, consis tent with the CBD and the International 
Undertaking on Plant Genetic Resources
142;  (ii) the continuation of traditional 
farming practices including the right to sav e and exchange seeds, and sell farmers' 
harvest;  and (iii)  the prevention of anti-competitive rights or practices which 
threaten the food sovereignty of developing co untries, as is permitted by Article 31 of 
the TRIPS Agreement;143 
  - provisions permitting specific exceptions to plant variety rights should be included in 
the TRIPS Agreement covering, as a minimum, farmers' rights,
144 in particular to sow 
and share harvested seed of a protected va riety, communities' rights and compulsory 
licensing where plant varieties are not available on reasonable commercial terms, in times of national emergency and in cases of public non-commercial use.
145   
 49. The views that have been expressed in res ponse to these suggestions are set out in the 
discussion below. 
B. "E
FFECTIVE SUI GENERIS  SYSTEMS " OF PROTECTION  
50. The question has been raised  as to what constitutes an "effective" system of sui generis  
protection for plant varieties for the purposes of Article  27.3(b).  In this respect, two views have been 
expressed: 
 - there are specific criteria availabl e to judge the effectiveness of a sui generis  
system;146 
  - the TRIPS Agreement does not specify criteria by which to judge whether a 
sui generis  system is effective and therefore this should be left to Members to 
decide.
147 
 
                                                      
140 African Group, IP/C/W/404, p.3. 
141 European Communities, IP/C/M/25, para. 74. 
142 See also the International Treaty on Plant Gene tic Resources for Food and Agriculture (2001) 
adopted on 3 November 2001  in Rome. See http://www.fa o.org/ag/cgrfa/itpgr.htm.  
143 Kenya on behalf of the African Group, IP/C/W/163.  
144 Peru, IP/C/M/37/Add.1, para. 217; Zimbabwe, IP/C/M/40, para. 79; Malaysia, IP/C/M/40, 
para. 128.  
145 Thailand, IP/C/M/25, para78. 
146 United States, IP/C/W/209.  
147 India, IP/C/M/25, para. 70; Zimbabwe, IP/C/M/36/Add.1, para. 201; African Group, IP/C/W/404, 
p.2; Kenya, IP/C/M/40, para. 108.  IP/C/W/369/Rev.1 
 Page 17 
 
 
  These views and responses made to specific points are elaborated below. 
51. The view has been expressed that, in order to be effective, a sui generis system of protection 
should possess the same basic characteristics as those th at generally apply in relation to the protection 
of property rights, whether real, tangible or intang ible:  the nature of the subject-matter must be 
identified clearly enough to enable a distinction to be drawn between what falls within and what is 
beyond the scope of the law;  who is entitled to ob tain property rights must be established;  the 
circumstances in which the rights exist and the limitations that apply must be spelt out;  the period during which the rights are in force and the circumstances, if any, under which the rights expire early or under which they can be extended must be specif ied;  and the legal action available to the right 
holder to enforce its rights along with the remedies available must be indicated, unless these are 
provided for in other laws such as a code of civil procedure.
148 
52. In regard to the subject-matter that should be protected , the view has been expressed that 
such subject matter should be clearly defined149 and for a sui generis  system to be considered 
effective, protection should apply to all plant varieties throughout the plant kingdom.150  It has been 
pointed out that, unlike the English and French versions of the text of the TRIPS Agreement, the 
Spanish version, which is as authen tic as the English and French versions, makes it clear that all plant 
varieties are to be protected.151  In response, the point has been made that Article 27.3(b) only speaks 
of a sui generis  system without providing specific details as to the plant varieties that should be 
protected.152   Further, it has been pointed out that some existing sui generis systems, such as in the 
UPOV, which appear to be considered effective mo dels given their long-standing use, do not require 
protection of the entire plant kingdom.153 
53. In regard to the conditions for granting protection, the view has been expressed that these 
should be clearly defined.154  It has been suggested that, in order to be eligible for protection, a variety 
should be:  new, i.e., the variety's propagating or harvested material should not have been sold or 
otherwise made available for purposes of explo itation of the variety;  it should be clearly 
distinguishable from other known varieties;  it should be uniform in that it does not vary beyond what 
would normally be expected;  and the characteri stics of the variety should not change through 
repeated propagation.155  In response it has been said that the suggested determinants of entitlement to 
protection, namely novelty, distinctiveness, unifo rmity and stability, go beyond the determinants 
contained in existing models.  For example, under th e UPOV system, novelty is strictly speaking not a 
criterion.  Further, protection under the Interna tional Undertaking on Plant Genetic Resources for 
Food and Agriculture156 or the CBD may entitle a farmer's vari ety to protection, even though such a 
variety might not be new. 157 
54. In regard to the rights with respect to the protected subject matter, the view has been 
expressed that , the right-holder should at least be able to prevent third parties from carrying out 
certain acts in relation to the protected subject matt er over a certain period of time and the law should  
provide for national treatment and most favoured nation treatment.158  With respect to who is entitled 
                                                      
148 United States, IP/C/W/209.  
149 European Communities, IP/C/W/383, para. 77. 
150 Uruguay, IP/C/M/28, para. 132. 
151 Uruguay, IP/C/M/28, para. 132. 
152 Peru, IP/C/M/32, para. 128. 
153 India, IP/C/M/29, para. 162; Thailand, IP/C/M/25, para. 78. 
154 European Communities, IP/C/W/383, para. 77. 
155 United States, IP/C/W/209.  
156 See also the International Treaty on Plant Gene tic Resources for Food and Agriculture (2001) 
adopted on 3 November 20 01 in Rome. See http://www. fao.org/ag/cgrfa/itpgr.htm. 
157 India, IP/C/M/29, para. 162. 
158 European Communities, IP/C/W/383, para. 77. IP/C/W/369/Rev.1 
Page 18  
 
  to obtain rights  under a sui generis  system of protection for plant varieties, the view has been 
expressed that an effective system should ensure that  protection for plant varieties is granted only to 
breeders or others specifically entitled to protec tion either through contract or law of succession.
159   
In response, it has been said that this would mean that, for example, farmers' rights that have arisen 
through tradition and not through contracts or succession cannot be protected. 160  In turn, it has been 
said that this would not prevent Members from protecting farmers' rights through other means;  it only 
meant that such protection would not be  an obligation under the TRIPS Agreement.161 
55. In regard to limitations and exceptions to the rights of the right-holder it has been 
suggested that these should include experimental use,  the right to use a protected variety for further 
breeding, compulsory licences and certain exceptions to the benefit of farmers.162  It has also been 
argued that regardless of of what sui generis  system is adopted for protecting plant varieties, non-
commercial use of plant varieties, the system of seed saving and exchange as well as the selling 
among farmers, are rights and exceptions that should be ensured as matters of important public policy 
to, among other things, ensure food security a nd preserve the integrity of rural or local 
communities.163  In this regard the scope of farmers' pr ivilege and the breeders' exemption has been 
discussed.  While the view has been  expressed that these exceptions pr ovide for a balance between the 
interests and needs of plant breeders and farmers164 and may ensure biodiver sity in accordance with 
the CBD,165 it has also been said that it is not clear that there is a commonality of views on the 
definition of these terms.  With regard to the breeders' exemption,  it has been said that it allows 
breeders to freely use plant varieties protected by  plant breeders' rights in  their breeding activities.166  
However, the question has been rais ed as to whether it is clearly understood that breeders are able to 
innovate around protected varieties without overly restrictive or prohibitive compensatory conditions 
in favour of the holders of rights in such varieties.167  In response, the view has been expressed that 
the breeders' exemption as contained in the UPOV Convention adequately deals with this concern.168 
56. With regard to farmers' privilege , it has been stated that this allows farmers to replant on 
their own holdings propagating material of protected plant varieties that they have harvested on their 
own holdings.169  It has been said that the issue of whethe r remuneration must be paid in relation to 
the exercise of the farmers' privilege  is left to the national legislator.170  In response it has been said 
that the farmers' privilege should not be limited to saving and re-planting the material only on a 
farmer's own holdings.171  It has been said that the TRIPS Ag reement would leave scope for certain 
farmers' exceptions both under pate nt and plant varieties protection law, provided they are limited to 
subsistence and small farmers and as long as the comme rcial interests of plant breeders are protected. 
While farmers who had an activity on a commercial scale should not benefit from farmers' exceptions, 
there is room for discussion regarding certain  categories of farmers in developing countries.172  Views 
                                                      
159 United States, IP/C/W/209.  
160 India, IP/C/M/29, para. 162. 
161 Switzerland, IP/C/M/30, para. 166, IP/C/W/284. 
162 European Communities, IP/C/W/383, para. 77. 
163 African Group, IPC/W/404, p.3. 
164 Japan, IP/C/W/236; Switzerland, IP/C/W/284; Norway, IP/C/M/43, para. 52. 
165 Kenya, IP/C/M/28, para. 142; Norway, IP/C/M/43, para. 52. 
166 Switzerland, IP/C/W/284. 
167 Mauritius, on behalf of the African Group IP/C/W/206. 
168 Switzerland, IP/C/W/284. 
169 European Communities, IP/C/M/25, para. 74; Sw itzerland, IP/C/M/29, para. 179; United States, 
IP/M/25, para. 71, IP/C/W/162. 
170 Switzerland, IP/C/W/284. 
171 Kenya, IP/C/M/28, para. 145; African Group, IPC/W/404, p.3. 
172 Canada, IP/C/M/40, para. 114; European Communities, IP/C/M/37/Add.1, para. 214, IP/C/M/43, 
para. 38; Norway, IP/C/M/43, para. 52.  IP/C/W/369/Rev.1 
 Page 19 
 
 
  have also been expressed about the way in which th e issue of farmers' privilege is treated in UPOV 
1991;  these are summarized in paragraph C.61 below. 
57. In regard to the period of application of the rights , the view has been expressed that this 
should be determined, but should be sufficient to a llow breeders to recover costs and invest in new 
research.173  In this regard, it has been suggested that the right holder should, for a period of at least 
20 years from the date rights are granted, be entitled to prevent others from commercializing or taking 
steps to commercialize the protected variety without th e authorization of the right holder.  A period of 
25 years should apply in relation to new varieties of trees and vines given that the development and 
commercialisation of such new varieties requires a longer period of time than that for other plant 
varieties.174  In response it has been said that the suggest ed term of protection of at least 20 years, 
which applies to patents in Section 5 of Part II of the TRIPS Agreement, does not apply to plant 
variety protection.  Effective sui generis  models, such as the UPOV system, may have a different term 
of protection.175  
58. In regard to the procedures to be followed by potent ial right holders to obtain rights , the 
view has been expressed that such procedures a nd any fees involved, should be provided for in a 
comprehensive and transparent way176 and should apply to foreign na tionals on a national treatment 
basis, as required by Article 3 of the TRIPS Agreemen t, with a provision for claiming a priority filing 
date based on filing in the right hol der's own country similar to that a pplicable to patents in the Paris 
Convention.177  In response it has been said that sui generis  models that reflect the practice of 
reciprocity rather than national treatment should not be deemed to be lowering the level of protection 
or the effectiveness of the sui generis  system.178  
59. With regard to the enforcement of rights and it has been suggested that, to create an effective 
deterrent to infringement, the law should provi de for legal and ins titutional implementation 
procedures.179  In this regard, the view has been expr essed that effectiveness depends upon the 
enforceability of a right within a national legal system.180  More particularly, it has been suggested 
that the legal actions that must be available to a right holder to enforce rights and the remedies that 
judicial and administrative authorities must be able  to impose on infringers s hould be those that are 
currently provided for in the TRIPS Agreement.181 
60. The view has also been expressed  that what can constitute "effective protection" as it relates 
to the protection of plant varieties, under the TRI PS Agreement, is left to Members to determine182 
and that the review should clarify that sui generis  systems are domestic laws adopted to protect plant 
varieties within the context of important domestic goals and other relevant international obligations.183  
In this respect, the view has been  expressed that the concept of a " sui generis " system is inconsistent 
with a prescription of rights and duration or ev en models to be imposed on all WTO Members.184  As 
a fair balance between the interests involved ma y vary between countries and over time, it is the 
responsibility of each Member to create a system that gives sufficient protection for the parties 
                                                      
173 European Communities, IP/C/W/383,  para. 77. 
174 United States, IP/C/W/209.  
175 India, IP/C/M/29, para. 162. 
176 European Communities, IP/C/W/383,  para. 77. 
177 United States, IP/C/W/209.  
178 India, IP/C/M/29, para. 162. 
179 European Communities, IP/C/W/383, para. 77.  
180 India, IP/C/M/25, para. 70. 
181 United States, IP/C/W/209; European Communities, IP/C/W/383, para. 77. 
182 Kenya, IP/C/M/28, para. 142; Kenya highlighting African Group submission, IP/C/M/25, para. 75; 
Zimbabwe, IP/C/M/36/Add.1, para. 201. 
183 Kenya, IP/C/M40, para. 109. 
184 Kenya, IP/C/M/28, para. 142. IP/C/W/369/Rev.1 
Page 20  
 
  involved.
185  The view has also been expressed that th e standards for patents might not necessarily be 
applicable, particularly for countries that have opted to create a sui generis  system rather than relying 
upon patents or a combination of systems including patents.186  
C. RELATIONSHIP BETWEEN THE TRIPS  REQUIREMENT TO HAVE AN EFFECTIVE SUI GENERIS  
SYSTEM AND THE UPOV  CONVENTION  
61. Views have been expressed as to whether the syst ems of plant variety protection provided for 
under UPOV constitute effective sui generis  systems for the purposes of Article 27.3(b).  One view 
has been that, while it is recognized that the TR IPS Agreement does not specifically call for a UPOV 
model to be followed, UPOV does provide for an effective sui generis  system as required by Article 
27.3(b).187  Several arguments have been made to support th is view and in favour of widespread use of 
UPOV: 
 - the UPOV system is the most favourable  for encouraging development of new plant 
varieties in all WTO Members' territories;188 
  - with respect to concerns that have b een expressed about the impact of the UPOV 
system on farmers and plant breeders especially in developing countries, the UPOV 
system is flexible enough to allow Member s to adequately address such concerns 
through, for example, the farmers' privilege and the breeders' exemption;
189 
  - recognizing the difficulties associated with the creation and administration of 
sui generis  systems for the protection of plant varieties, the most efficient and rapid 
way to implement Article 27.3(b) would be  to rely on existing harmonised plant 
variety systems with possible adaptati ons to ensure special national needs;
190 
 
- lack of a uniform system like UPOV could reduce market access for small plant 
breeders and biotech developers because maintaining protection in other markets 
would be more time consuming and costly;191 
 - the uniformity provided by the UPOV system would facilitate trade in new plant 
varieties;
192 
 - a growing number of countries have signed on to UPOV and the number of protected 
varieties under UPOV is increasing.
193 
  62. In response, the view has been expressed that a reference to UPOV would not be 
appropriate,
194 for the following reasons: 
                                                      
185 Norway, IP/C/M/43, para. 51; IP/C/W/293.   
186 India, IP/C/M/29, para. 162, Thailand, IP/C/M/42, para. 115. 
187 European Communities, IP/C/M/25, para. 74; Japa n, IP/C/W/236, IP/C/M/40, para. 98; Switzerland, 
IP/C/M/30, para. 166; United States, IP/C/W/162; Uruguay, IP/C/M/28, para. 132. 
188 United States, IP/C/M/30 para. 175. 
189 Japan IP/C/W/236;  Switzerland, IP/C/M/32, para. 123; Norway, IP/C/M/43, para. 51. 
190 European Communities, IP/C/M/25, para. 74. 
191 United States, IP/C/M/37/Add.1, para. 210. 
192 United States, IP/C/M/37/Add.1, para. 210. 
193 European Communities, IP/C/M/37/Add.1, para. 212; Japan, IP/C/M/40, para. 98. 
194 Norway, IP/C/M/25, para. 76.  IP/C/W/369/Rev.1 
 Page 21 
 
 
   - Article 27.3(b) does not bind Members to use UPOV as a model in providing 
protection for plant varieties, although UPOV may be an important point of reference.
195   More particularly, Members are free to choose a model other than 
UPOV, such as those based on FAO's International Undertaking on Plant Genetic Resources or the CBD, if they so desire.
196 The appropriate and beneficial approach is 
to have systems of protection that can address the local realities and needs.197 
  - incorporation of a reference to UPOV in to Article 27.3(b) could damage the delicate 
balance already established in that provision;
198 
 
 - there is no authoritative interpretation as to whether UPOV satisfies the requirements 
contained in Article 27.3(b);199 
  - UPOV is premised on the protection of plant breeders in industrialized countries 
rather than the needs of users in developing countries, although the 1978 Act of 
UPOV allows the recognition of farmers’ privilege to re-sow farm-saved seeds.
200 
 63. In response, it has been said that the reason why a reference to UPOV does not appear in 
Article 27.3(b) is because of its limited geographi c coverage at the time the TRIPS Agreement was 
being negotiated.
201  While there may be sui generis  systems for the protection of plant varieties other 
than UPOV that meet the requirements of Article 27.3(b)202 and may be equally effective203, such 
systems would have to be judged on their merits on a case by case basis.204  It has also been said that 
Members may implement a minimum set of standards in order to meet their TRIPS obligations.205 
64. Differing views have been expressed on the mer its of the various UPOV conventions and 
their relationship to the TRIPS Agreement.  In regard to UPOV 1991 , one view has been that it 
achieves a proper balance of rights and obligations wh ich work to the benefit of all countries and that 
UPOV 1991 provides the most appropriate system and level of protection.206  In this regard, the point 
has been made that the 1991 Act of UPOV does not permit contracting parties to limit the eligibility 
for protection of varieties by species of plant.  This  means that newly developed varieties of species of 
plant that would not have been eligible for protection under the 1978 Act are now eligible for 
protection under the 1991 Act.  However, under UPOV 1991, contracting parties can limit rights so as to permit farmers to save seeds harvested from thei r own plantings for replanting in subsequent 
years.
207  The point has also been made that most Members that responded to the questionnaire on the 
                                                      
195 Brazil, IP/C/M/30, para. 183, IP/C/M/25, para. 94; India, IP/C/W/161, page 4; Malaysia, 
IP/C/M/37/Add.1, para. 202, IP/C/M/29, para. 206, IP/C/M/25, para. 83; Mexico, IP/C/M/26, para. 76; Singapore, IP/C/M/30, para. 172; Zambia, IP/C/M/28, para. 147; Zimbabwe, IP/C/M/36/Add.1, para. 201; 
African Group, IP/C/W/404, p.2. 
196 Brazil, IP/C/M/30, para. 183; India IP/C/W/1 61; Zambia, IP/C/M/28, para. 147; Zimbabwe, 
IP/C/M/36/Add.1, para. 201; African Group, IP/C/W/404, p.2.  
197 African Group, IP/C/W/404, p.3. 
198 Brazil, IP/C/M/26, para. 60. 
199 India, IP/C/M/25, para. 70; Thailand, IP/C/M/25 para. 78. 
200 India, IP/C/W/161.  
201 Switzerland, IP/C/M/25, para. 82. 
 202 Switzerland, IP/C/M/30, para. 166; United States, IP/C/W/162. 
203 Brazil, IP/C/M/37/Add.1, para. 208; Europ ean Communities, IP/C/M/37/Add.1, para. 212, 
IP/C/M/43, para. 38, Norway, IP/C/M/43, para. 53. 
 
 204 Switzerland, IP/C/M/30, para. 166; United States, IP/C/W/162. 
205 Canada, IP/C/M/40, para.114. 
206 European Communities, IP/C/M/25, para. 74; Sw itzerland, IP/C/M/24, para. 79; United States, 
IP/C/M/25, para. 71, IP/C/W/162. 
207 European Communities, IP/C/M/25, para. 74; Un ited States, IP/C/M/25, para. 71, IP/C/W/162. IP/C/W/369/Rev.1 
Page 22  
 
  implementation of Article 27.3( b) have adopted the 1991 Act
208 and that many of those that had 
originally become signatories to the 1978 Act were in the process of ratifying the 1991 Act.209   
65. In response, it has been said that, while member ship of the 1991 Act of UPOV is increasing, a 
large number of developing countries are resisting si gning the instrument given its limited flexibility 
as compared with the 1978 Act .  In this regard the view has been expressed that UPOV 1978 allows 
farmers to save, exchange and, to a limited degree,  sell seeds of protected varieties, whereas UPOV 
1991 turns these actions into privileges and excep tions, giving the government discretion as to 
whether to permit farmers to save seeds for use on their own holdings and making it subject to 
"reasonable restrictions" and the protection of the "legitimate interests" of the breeder.  Further, the exception only applies to saved material th at has been harvested on the same holdings
210 and not to 
propagated material.211  The terminator technology and pove rty in developing countries renders the 
exceptions in UPOV 1991 meaningless. 212  Since the food security of local communities in most 
developing countries depends largely on their savin g, sharing and replanting seeds from the previous 
harvest, the possibility of having to pay fees for engaging in such activities, as is permitted under 
UPOV 1991, would negatively affect small rura l producers and result in social imbalances.213  The 
result would be food insecurity and depende nce on commercial breeders abroad for seeds.214  Further, 
UPOV 1991 limits exhaustion of the right to sell or ot herwise market plant varieties made within the 
national territory of the contracting party concer ned, which might distur b the negotiated balance 
struck by Article 6 of the TRIPS Agreement.215  The view has been expressed that, from the 
perspective of developing country Members, th e 1978 UPOV Act remains a useful reference for 
discussions, even if that instrument is no longer open for membership.216  Legislation based upon 
UPOV 1978 should be regarded as providing effective protection for plant variety rights for the 
purposes of Article 27.3(b).217  
66. In response it has been stated that the fa rmers' exemption can be justified under 
Article 27.3 (b) as an exception to plant variet y protection or under Article 30 of the TRIPS 
Agreement as an exception to patent protection on genetic resources for food and agriculture, as the 
case may be.218  There is no need to change the word ing of the TRIPS Agreement to allow the 
national legislator to introduce the farm ers' privilege in national patent laws.219   Least-developed and 
developing countries whose farming activities are limite d to small farms at subs istence level or where 
commercial activities of farmers are of limited geographical source, could create within their national laws broader farmers' exemptions  for the benefit of subsistence farmers or small farmers who 
customarily reuse seed because th ey lack access to financial resources for new seeds every growing 
season.
220 
                                                      
208 Switzerland, IP/C/M/24, para. 79; United States, IP/C/M/24 para. 76. 
209 Switzerland, IP/C/M/24, para. 79. 
210 Kenya, IP/C/M/28, para. 145. 
211 Kenya, IP/C/M/40, para 108. 
212 Kenya, IP/C/M/40, para 108. 
213 Brazil, IP/C/W/228.  
214 Kenya, IP/C/M/40, para 108. 
215 Brazil, IP/C/W/228.  
216 Brazil, IP/C/M/26, para. 60. 
217 Mexico, IP/C/M/25, para. 90. 
218 European Communities, IP/C/M/37Add.1, para. 213, IP/C/W/383, para. 86; Brazil, 
IP/C/M/37/Add.1 para. 208. 
219 Switzerland, IP/C/W/400/Rev.1, para. 22; Bangladesh, IP/C/M/42, para. 102; European 
Communities, IP/C/M/42, para. 108.  
220 European Communities, IP/C/M/37/Add.1, para. 214 , IP/C/M/40, para. 94, IP/C/M/42, para. 108, 
IP/C/M/43, para. 38,  IP/C/W/383, para. 88; Malaysia, IP/C/M/40, para 128.  IP/C/W/369/Rev.1 
 Page 23 
 
 
  D. RELATIONSHIP BETWEEN  SUI GENERIS  PROTECTION OF PLANT VARIETIES AND TRADITIONAL 
KNOWLEDGE AND FARMERS ' RIGHTS  
67. The view has been expressed that laws and measures on the protection of plant varieties 
directly affect traditional knowledge and farmers' rights.221  In this respect, it has been noted that 
staple or medicinal plants would not qualify fo r protection under UPOV given their long-standing 
existence, thus not protecting the trad itional knowledge relating to their use.222  The point has been 
made that such traditional knowledge has been recognized under a number of international instruments, such as the CBD, th e FAO International Undertaking on Plant Genetic Resources, and 
the OAU model law.
223  The view has been expressed that syst ems for the protection of plant varieties 
may support or harm such rights, depending on whet her or not the laws and measures strike a balance 
between the various key interests and whether or  not farmers' rights and traditional knowledge are 
duly recognized and provided for.224  It has been suggested that  the flexibility provided in 
Article 27.3(b) should therefore be retained and construed consistently with the aforementioned 
instruments.225  More particularly, the view has been e xpressed that the protection of plant varieties 
should recognize the contribution of farming a nd indigenous communities to genetic resource 
conservation and enhancement,226 should be equitable and sh ould ensure biodiversity.227  
68. In response, the view has been expressed that, although the TRIPS Agreement does not 
specifically determine the subject matter to be protected by the sui generis  system of protection and 
does not define the term "plant variety", the results  of commercial plant breeding are likely to be the 
primary subject matter to be protected by a sui generis  system, taking into consideration the overall 
objectives of the TRIPS Agreement.228  Reference has been made in this respect to the definition of 
the term "plant variety" contained in Article  1(vi) of the 1991 Act of the UPOV Convention.229  
Nevertheless, it has been stated, the TRIPS Agreement does not preclude Members from implementing a sui generis  system of protection for farmers' varieties or so-called "landraces," which 
generally have characteristics that differ from commercial plant varieties and might, therefore, require their own system of protection.
230   
69. It has been stated that Member s are free to protect farmers' rights as defined in Article 15.2 of 
the draft for a revised International Undert aking on Plant Genetic Resources for Food and 
Agriculture,231 but that the farmers' rights currently defined in the International Undertaking cover 
plant genetic resources and not plant varieties.232  Furthermore, the definition of farmers' rights is not 
specific enough to be "an effective sui generis  system" as required by Article 27.3(b) of the TRIPS 
Agreement.  Therefore, the view has been expressed  that national legislation would have to further 
define farmers' rights in order to sa tisfy the requirement of "an effective sui generis  system" under 
Article 27.3(b).233  It has been said that the provisions of  the International Undertaking and the CBD, 
on the one hand, and the TRIPS provisions regarding sui generis  protection of plant varieties on the 
                                                      
221 Mauritius on behalf of the African Group, IP/C/W/206. 
222 Kenya, IP/C/M/28, para. 145. 
223 Kenya, IP/C/M/28, para. 145; Mauritius on behalf of the African Group, IP/C/W/206; Zimbabwe, 
IP/C/M/36/Add.1, para. 201. 
224 Mauritius on behalf of the African Group, IP/C/W/206; Zimbabwe, IP/C/M/36/Add.1, para. 201. 
225 Kenya, IP/C/M/28, para. 145; Mauritius on behalf of the African Group, IP/C/W/206;. 
226 Zambia, IP/C/M/28, para. 147; Zimbabwe, IP/C/M/36/Add.1, para. 201. 
227 Kenya, IP/C/M/28, para. 142. 
 228 Switzerland , IP/C/W/284. 
 
 229 Switzerland, IP/C/W/284. 
230 Switzerland, IP/C/M/30, para. 166, IP/C/W/284. 
231 The International Treaty on Plan t Genetic Resources for Food and Agriculture (2001) adopted on 
3 November 2001 in Rome deals with Farmers' Rights in its Article 9. 
 232 Switzerland, IP/C/W/284. 
233 Switzerland, IP/C/W/284. IP/C/W/369/Rev.1 
Page 24  
 
  other hand can and should be implem ented in a mutually supportive way.
234  The view has also been 
expressed that farmers' rights are part of a much broader issue and are appropr iately being dealt with 
in other organisations, in particular the FAO.235 
IV. TRANSFER OF TECHNOLOGY 
70. In the work of the Council for TRIPS, the issue of the implications of patent protection in 
respect of life forms and sui generis  plant variety protection for access to, and transfer and 
dissemination of, technology has been discussed.  This discussion has taken place in a number of 
contexts, including in relation to developmental matters and the relationship between the TRIPS 
Agreement and the objectives and provisions of th e CBD concerning access to and the transfer of 
technology.  It has been recalled that Article 7 of the TRIPS Agreement includes the transfer and 
dissemination of technology as one of the basic objectives of the protection of intellectual property 
rights and the need for measures to effectiv ely operationalize this has been referred to.236  It has been 
said that access by the developing world to these im portant technologies, as well as their capacity to 
deal with the potential risks associated with  these technologies remains limited. Agricultural 
technology and biotechnology in particular are theref ore important issues to be tacked in the context 
of transfer of technology and capacity building.237 
71. In the discussion, one view has been to put em phasis on the concern that intellectual property 
rights in respect of life forms and genetic materi al could impede access to, and raise the cost of 
technology in this area, by virtue of the exclusive rights given to right holders to prevent others from using the protected technology.  It has been said that the issue of whether and how IPRs such as 
patents and plant breeders' rights lead to the relo cation of investment, transfer and dissemination of 
technology and research and deve lopment in developing countri es needs to be examined.
238 
72. In response, it has been said that full implementation of TRIPS provisions, including those in 
Article 27.3(b) by developing countries, would bui ld confidence among investors, both domestic and 
foreign, stimulating investment in inno vative and creative businesses in these countries.239  It has been 
said that where technology is in the hands of the pr ivate sector, it can be tran sferred most effectively 
through market mechanisms such as licensing and that  for licensing agreements adequate intellectual 
property protection is an important premise.  Expe rience shows that the benefits to recipients and 
users of technology exceed the cost of acquiring that  technology and that they can in time themselves 
become producers of follow-up technology.240  The importance of the patent system for discouraging 
secrecy and its disclosure requirements for facili tating the dissemination of technological and 
scientific knowledge has already been referred to.241  
73. Concern has been expressed that  excessively broad patent rights in the area of biotechnology 
may impede the use of micro-organisms and ge netic material by others for research purposes.242  In 
response, it has been said that the TRIPS Agreem ent leaves scope to WTO Members to provide for 
exclusions from patent rights to allow use for rese arch purposes and that this is also the case for 
sui generis  plant variety protection, as made clear by the breeders' exception required under UPOV 
1991.  The point has been made that this access to protected technology for research purposes should 
                                                      
234 Switzerland, IP/C/W/284. 
235 European Communities, IP/C/M/35, para. 215. 
236 Mauritius on behalf of the African Group, IP/C/W/206. 
237 EC, IP/C/W/383, para. 15.  
238 Mauritius on behalf of the African Group, IP/C/W/206. 
239 United States, IP/C/W/257, IP/C/M/29, para. 184. 
240 Japan, IP/C/W/236. 
241 Switzerland, IP/C/W/284. 
242 Brazil, IP/C/W/228.  IP/C/W/369/Rev.1 
 Page 25 
 
 
  be considered part of benefit sharing, as was rec ognized in the work underway in the context of the 
FAO International Undertaking on Plant Genetic Resources. 243 
74. In regard to benefit sharing, reference ha s been made to the requirements in the CBD 
regarding the provision of access to and transfer of technology to developing countries, especially that 
which makes use of genetic resources that they have  provided.  This discussion is summarized in the 
note on the relationship between the TRIPS Agreement and the CBD.   
V. INFORMATION ON NATIONAL LEGISLATION, PRACTICES AND 
EXPERIENCES 
75. At its meeting in December 1998, the Council fo r TRIPS invited Members that were already 
under an obligation to apply Article 27.3(b) to pr ovide information on how the matters addressed in 
this provision were treated in their national law.   Other Members were invited to provide such 
information on a best endeavour basis.  A questionna ire was circulated by the Secretariat in document 
IP/C/W/122 and an alternative questionnaire was ci rculated by Canada, th e European Communities, 
Japan and the United States in document IP/C/W/126.   The information provided by Members in 
response has been summarized by the Secretariat in  the synoptic tables in document IP/C/W/273 and 
document IP/C/W/273/Rev.1.  Since the preparation of that document additional responses have been 
received from Moldova and Peru, which are listed in the Annex to this document. 
76. The following Members have made submissions or comments on their national legislation, 
practices or experiences in the discussions in the Council for TRIPS:  Australia244, Canada245, 
China246, European Communities,247 India,248 Peru,249 Switzerland250 and the United States.251 
                                                      
243 European Communities, IP/C/W/254.  This process came to an end with the adoption of the 
International Treaty on Plant Genetic Resources for Food and Agriculture on 3 November 2001. 
244 Australia, IP/C/W/310. 
245 Canada, IP/C/M/40, para. 112, 114. 
246 China, IP/C/M/37/Add.1, para. 201; IP/C/M/37/Add.1/Corr.1. 
247 European Communities, IP/C/M/37/Add.1, para 213, IP/C/W/383, para. 29. 
248 India, IP/C/W/198. 
249 Peru, IP/C/W/441; IP/C/W/441/Rev.1; IP/C/W/447. 
250 Switzerland, IP/C/W/400/Rev.1, para. 21. 
251 United States, IP/C/M/37/Add.1, para. 211;  IP/C/M/39, para. 114. IP/C/W/369/Rev.1 
Page 26  
 
  ANNEX 
 
DOCUMENTS OF THE COUNCIL FOR TRIPS WITH RESPECT TO THE REVIEW OF 
THE PROVISIONS OF ARTICLE 27.3(B), THE RELATIONSHIP BETWEEN TRIPS  
AND THE CONVENTION ON BIOLOGICAL DIVERSITY AND THE  
PROTECTION OF TRADITIONAL KNOWLEDGE  
AND FOLKLORE 
  
 The reports on the meetings of the Council fo r TRIPS held during the period January 1999 to 
January 2006 (IP/C/M/21-35, 36/Add.1, 37/Add.1, 38 -40 and 42-49) reflect the work done so far in 
the Council for TRIPS with respect to three agenda items, namely, the review of the provisions of 
Article 27.3(b);  the relationship between the TR IPS Agreement and the Convention on Biological 
Diversity (CBD);  and the protection of traditional knowledge and folklore (List A).  The substantive 
discussions in the Council for TRIPS on these issues ha ve been recorded in the reports of the meetings 
held from August 1999 to January 2006 (IP/C/M /24-35, 36/Add.1, 37/Add.1, 38-40 and 42-49). 
 Other documents that have been made available include: 
  - Members' submissions relating to specific issues.  Over the period December 1998 to 
November 2005, 51 papers have been subm itted by Members or groups of Members 
(List B). 
 - Information on national legislation, pr actices and experiences provided by eight 
Members (List C) 
- Responses to the questionnaire on Artic le 27.3(b) from 25 Members (List D). 
 - Information provided on work in inte rgovernmental organizations (List E). 
 - Notes by the Secretariat on relevant issues under discussion in the Council for TRIPS 
(List F).  
  IP/C/W/369/Rev.1 
 Page 27 
 
 
  LIST A – Records of the work of the Council for TRIPS 
IP/C/M/21-35, 36/Add.1, 
37/Add.1, 38-40 and  42-49 Minutes of the Council for TRIPS Meetings 22 January 1999 - 
31 January 2006 
 
LIST B - Members' submissions relating to the agenda items 
2005 
Bolivia, 
Brazil, 
Colombia, 
Cuba, India, and Pakistan IP/C/W/459 The Relationship between the TRIPS 
Agreement and the CBD, and the Protection 
of Traditional Knowledge - Technical 
Observations on US Submission IP/C/W/44918 November 2005 
Peru IP/C/W/458 Analysis of Potentia l Cases of Biopiracy 7 November 2005 
United States IP/C/W/449 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD, and the Protection of Traditional Knowledge and 
Folklore 10 June 2005 
Peru IP/C/W/447 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 8 June 2005 
Switzerland IP/C/W/446 The Relationship between the TRIPS 
Agreement and the CBD, and the Protection of Traditional Knowledge  and Folklore and 
the Review of Implementation of the TRIPS 
Agreement under Article 71.1 30 May 2005 
Brazil, India IP/C/W/443 The Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge:  Technical Observations on Issues Raised in a Communication by the United States 
(IP/C/W/434) 18 March 2005 
Bolivia, 
Brazil, 
Colombia, Cuba, Dominican Republic, 
Ecuador, 
India, Peru, Thailand IP/C/W/442 The Relationship between the TRIPS 
Agreement and the Convention on Biological 
Diversity (CBD) and the Protection of Traditional Knowledge - Elements of the Obligation to Disclose Evidence of Benefit-Sharing under the Relevant National Regime18 March 2005 
Peru  IP/C/W/441/ 
Rev.1 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 19 May 2005 
Peru IP/C/W/441 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and 
Protection of Traditional Knowledge and 
Folklore 8 March 2005 IP/C/W/369/Rev.1 
Page 28  
 
  LIST B - Members' submissions relating to the agenda items 
Dominican 
Republic IP/C/W/429/ 
Rev.1/Add.3 Request of the Dominican Republic to be 
added to the List of Sponsors of Document IP/C/W/429/Rev.1 10 February 2005 
Colombia IP/C/W/429/ 
Rev.1/Add.2 Request of Colombia to be added to the List 
of Sponsors of Document IP/C/W/429/Rev.120 January 2005 
2004 
Bolivia, 
Brazil, Cuba, Ecuador, India, 
Pakistan, Peru, 
Thailand, Venezuela IP/C/W/438 The Relationship between the 
TRIPS Agreement and the Convention on Biological Diversity (CBD), and the Protection of Traditional Knowledge - 
Elements of the Obligation to Disclose 
Evidence of Prior Informed Consent under the Relevant National Regime 10 December 2004 
United States IP/C/W/434 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD, and the 
Protection of Traditional Knowledge and 
Folklore 26 November 2004 
Switzerland IP/C/W/433 Further Observations by Switzerland on its 
Proposals regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications 25 November 2004 
Bolivia IP/C/W/429/ 
Rev.1/Add.1 Request from Bolivia to be added to the List 
of Sponsors of document IP/C/W/429/Rev.1 14 October 2004 
Brazil, Cuba, 
Ecuador, India, 
Pakistan, 
Peru, Thailand and Venezuela IP/C/W/429/ 
Rev.1 Revised Version of Document IP/C/W/429 
and Request from Cuba and Ecuador to be added to the List of Sponsors 27 September 2004 
Brazil, India, 
Pakistan, Peru, Thailand and 
Venezuela IP/C/W/429 Elements of the Obligation to Disclose the 
Source and Country of Origin of Biological Resources and/or Traditional Knowledge Used in an Invention 21 September 2004 
Switzerland IP/C/W/423 Additional Comments by Switzerland on its 
Proposal Submitted to WIPO Regarding the Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications 14 June 2004 
Bolivia IP/C/W/420/ 
Add.1 Request of Bolivia to be added to the List of 
Sponsors of Document IP/C/W/420 5 March 2004 
Brazil, Cuba, 
Ecuador, 
India, Peru, 
Thailand and Venezuela IP/C/W/420 The Relationship Between the 
TRIPS Agreement and the Convention on 
Biological Diversity (CBD) - Checklist of 
Issues 2 March 2004  IP/C/W/369/Rev.1 
 Page 29 
 
 
  LIST B - Members' submissions relating to the agenda items 
2003 
African Group IP/C/W/404 Taking Forward the Review of Article 
27.3(b) of the TRIPS Agreement 
 26 June 2003 
Bolivia, 
Brazil, Cuba, Dominican Republic, 
Ecuador, 
India, Peru, Thailand, Venezuela IP/C/W/403 The Relationship between the TRIPS 
Agreement and the Convention on Biological Diversity and the Protection of Traditional Knowledge 24 June 2003 
Switzerland IP/C/W/400/ 
Rev.1 Article 27.3(b), the Relationship between the 
TRIPS Agreement and the Convention on Biological Diversity, and the Protection of 
Traditional Knowledge 18 June 2003 
Switzerland IP/C/W/400 Article 27.3( b), the Relationship between the 
TRIPS Agreement and the Convention on 
Biological Diversity, and the Protection of Traditional Knowledge 28 May 2003 
United States IP/C/W/393 Access to Ge netic Resources Regime of the  
United States National Parks 28 January 2003 
2002 
European 
Communities 
and member 
States IP/C/W/383 Review of Article 27.3(B) of the 
TRIPS Agreement, and the Relationship 
between the TRIPS Agreement and the 
Convention on Biological Diversity (CBD) and the Protection of Traditional Knowledge and Folklore 17 October 2002 
Peru IP/C/W/356/ 
Add.1 Request of Peru to be added to the List of 
Sponsors of Document IP/C/W/356 1 November 2002 
Brazil, China, 
Cuba, 
Dominican 
Republic, Ecuador, India, Pakistan, 
Thailand, 
Venezuela, Zambia and Zimbabwe IP/C/W/356 
 The Relationship between the TRIPS 
Agreement and the Convention on Biological 
Diversity and the Protection of Traditional 
Knowledge  24 June 2002 
United States IP/C/W/341 Technology Transfer Practices of the US 
National Cancer Institute’s Departmental Therapeutics Programme 25 March 2002 
2001 
Australia IP/C/W/310 Communication from Australia:  Review of 
Article 27.3(b) 2 October 2001 IP/C/W/369/Rev.1 
Page 30  
 
  LIST B - Members' submissions relating to the agenda items 
EC IP/C/W/254 Review of the Provisions of Article 27.3(b) o f 
the TRIPS Agreement:  Communication from the European Communities and their Member States  13 June 2001 
Norway IP/C/W/293 Communication from Norway:  Review of 
Article 27.3(b) of the TRIPS Agreement:  The Relationship between the TRIPS Agreement and the Convention on Biological Diversity 29 June 2001 
Switzerland IP/C/W/284 Communication from Switzerland:  Review 
of Article 27.3(b):  The View of Switzerland 15 June 2001 
United States IP/C/W/257 Communication from the United States - 
Views of the United States on the 
Relationship between the Convention on 
Biological Diversity and the TRIPS Agreement 13 June 2001 
2000 
Brazil IP/C/W/228 Review of Article 27.3(b) - Communication 
from Brazil 24 November 2000 
India IP/C/W/195 Communication from India 12 July 2000 
India IP/C/W/196 Communication from India 12 July 2000  
India JOB(00)/6091 Non-paper by India:  Issues for Discussion 
under the Review of the Provisions of Article 27.3(b) of the TRIPS Agreement 5 October 2000 
Japan  IP/C/W/236 Review of the Provisions of Article 27.3(b) -  
Japan's View  11 December 2000 
Mauritius IP/C/W/206 Communication from Mauritius on behalf of 
the African Group 20 September 2000 
Singapore JOB(00)/7853 Non-paper by Singa pore - Article 27.3(b) 11 December 2000 
United States IP/C/W/209 Review of the Provisions of Article 27.3(b) - 
Further Views of the United States - Communication from the United States 3 October 2000 
1999 
Andean Group IP/C/W/165 Review of the Provisions of Article 27.3(b) - 
Proposal on Protection of the Intellectual 
Property Rights Relating to the Traditional Knowledge of Local and Indigenous Communities - Communication from Bolivia, Colombia, Ecuador, Nicaragua and Peru 3 November 1999 
Canada, EC, 
Japan and the United States IP/C/W/126 Review of the Provisions of Article 27.3(b) - 
Communication from Canada, the European Communities, Japan and the United States 5 February 1999 
Brazil IP/C/W/164 Review of the Provisions of Article 27.3(b) -  
Communication from Brazil 29 October 1999  IP/C/W/369/Rev.1 
 Page 31 
 
 
  LIST B - Members' submissions relating to the agenda items 
Cuba, 
Honduras, Paraguay and Venezuela IP/C/W/166 Review of Implementation of the Agreement 
under Article 71.1:  Proposal on Protection of the Intellectual Property Rights of the Traditional Knowledge of Local and 
Indigenous Communities 5 November 1999 
India IP/C/W/161 Review of the Provisions of Article 27.3(b) - 
Communication from India 3 November 1999 
African Group IP/C/W/163 Review of the Provisions of Article 27.3(b) -
Communication from Kenya on behalf of the African Group 8 November 1999 
Norway IP/C/W/167 Review of the Provisions of Article 27.3(b) - 
Communication from Norway 3 November 1999 
United States IP/C/W/162 Review of the Provisions of Article 27.3(b) - 
Communication from the United States 29 October 1999 
1998 
Mexico Job No. 6957 Non-paper from Mexico:  Application of 
Article 27.3(b)  8 December 1998 
 
LIST C – Information on national legislation, practices and experiences 
2006 
Norway IP/C/M/49, 
para. 120 Minutes of the Council for TRIPS Meeting 31 January 2006 
Peru IP/C/M/49, 
paras. 81-84 Minutes of the Council for TRIPS Meeting 31 January 2006 
2005 
Peru  IP/C/W/458 Analysis of Poten tial Cases of Biopiracy 7 November 2005 
India IP/C/M/48, 
paras. 57-59 Minutes of the Council for TRIPS Meeting 15 September 2005 
Norway IP/C/M/48, 
para. 81 Minutes of the Council for TRIPS Meeting  15 September 2005 
Peru IP/C/W/447 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 8 June 2005 
Peru  IP/C/W/441/ 
Rev.1 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and 
Protection of Traditional Knowledge and Folklore 19 May 2005 
Peru IP/C/M/47, 
paras. 16-23 Minutes of the Council for TRIPS Meeting 3 June 2005 
Peru IP/C/W/441 Article 27.3(b), Relationship between the 
TRIPS Agreement and the CBD and Protection of Traditional Knowledge and Folklore 8 March 2005 
Australia IP/C/M/46, 
para. 63 Minutes of the Council for TRIPS Meeting 11 January 2005 IP/C/W/369/Rev.1 
Page 32  
 
  LIST C – Information on national legislation, practices and experiences 
2004 
Peru IP/C/M/45, 
para. 31 Minutes of the Council for TRIPS Meeting 27 October 2004 
Chinese 
Taipei IP/C/M/43, 
para. 58 Minutes of the Council for TRIPS Meeting 7 May 2004 
EC IP/C/M/43, 
para. 39 Minutes of the Council for TRIPS Meeting 7 May 2004 
Norway IP/C/M/43, 
para. 54 Minutes of the Council for TRIPS Meeting 7 May 2004 
EC IP/C/M/42, 
para. 108 Minutes of the Council for TRIPS Meeting 4 February 2004 
United States IP/C/M/42, 
para. 110 Minutes of the Council for TRIPS Meeting 4 February 2004 
2003 
Norway IP/C/M/40, 
paras. 87-88 Minutes of the Council for TRIPS Meeting 22 August 2003 
Norway IP/C/M/39, 
para. 121 Minutes of the Council for TRIPS Meeting 21 March 2003 
Peru IP/C/M/38, 
para. 245 Minutes of the Council for TRIPS Meeting 5 February 2003 
United States IP/C/W/393 Access to Ge netic Resources Regime of the  
United States National Parks 28 January 2003 
2002 
India  IP/C/M/37/ 
Add.1, para. 253 Minutes of the Council for TRIPS Meeting 8 November 2002 
New Zealand IP/C/M/37/ 
Add.1, para. 248 Minutes of the Council for TRIPS Meeting 8 November 2002 
Peru IP/C/M/36/ 
Add.1, para. 
204 Minutes of the Council for TRIPS Meeting 10 September 2002 
United States IP/C/W/341 Technology Transfer Practices of the US  
National Cancer Institute’s Departmental Therapeutics Programme - Communication from the United States 25 March 2002 
2001 
Australia IP/C/W/310 Communication from Australia:  Review of 
Article 27.3(b) 2 October 2001 
Peru IP/C/W/246 Communication from Peru:  Peru's 
Experience of the Protection of Traditional Knowledge and Access to Genetic Resources14 March 2001 
2000 
India IP/C/W/198 Protection of Biodiversity and Traditional 
Knowledge - The Indian Experience 14 July 2000 
 
  IP/C/W/369/Rev.1 
 Page 33 
 
 
  LIST D - Information on Review of the Provisions of Article 27.3(b) 
2004 
Moldova IP/C/W/125/ 
Add.24 Review of the Provisions of Article 27.3(b) -  
Information from Members - Addendum 26 January 2004 
2002 
Lithuania IP/C/W/125/ 
Add.23 Review of the Provisions of Article 27.3(b) -  
Information from Members - Addendum 22 July 2002 
2001 
Czech 
Republic IP/C/W/125/ 
Add.8/Suppl.1 Review of the Provisions of Article 27.3(b) - 
Information from Members - Supplement 18 September 2001 
Thailand IP/C/W/125/ 
Add.22 Review of the Provisions of Article 27.3(b) - 
Information from Members - Addendum 10 August 2001 
Hong Kong, 
China IP/C/W/125/ 
Add.21 Review of the Provisions of Article 27.3(b) - 
Information from Members - Addendum 10 July 2001 
Estonia IP/C/W/125/ 
Add.20 Review of the Provisions of Article 27.3(b) - 
Information from Members - Addendum 2 July 2001 
2000 
Iceland  IP/C/W/125/ 
Add.19 Review of the Provisions of Article 27.3(b) - 
Information from Members - Addendum 17 July 2000 
1999 
Slovak 
Republic IP/C/W/125/ 
Add.18 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 27 July 1999 
Norway IP/C/W/125/ 
Add.17 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 19 May 1999 
South Africa IP/C/W/125/ 
Add.16/Corr.1 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum -Corrigendum 25 May 1999 
South Africa IP/C/W/125/ 
Add.16 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 21 April 1999 
Switzerland IP/C/W/125/ 
Add.15 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 13 April 1999 
Morocco IP/C/W/125/ 
Add.14 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 20 April 1999 
Australia IP/C/W/125/ 
Add.13 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 March 1999 
Canada IP/C/W/125/ 
Add.12 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 12 March 1999 
Poland IP/C/W/125/ 
Add.11 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 12 March 1999 
Slovenia IP/C/W/125/ 
Add.10 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 February 1999 
Korea IP/C/W/125/ 
Add.9 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 February 1999 
Czech 
Republic IP/C/W/125/ 
Add.8 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 February 1999 
Japan IP/C/W/125/ 
Add.7 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 12 March 1999 IP/C/W/369/Rev.1 
Page 34  
 
  LIST D - Information on Review of the Provisions of Article 27.3(b) 
Romania IP/C/W/125/ 
Add.6 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 February 1999 
United States IP/C/W/125/ 
Add.5 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 20 April 1999 
European 
Communities IP/C/W/125/ 
Add.4 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 10 February 1999 
Zambia IP/C/W/125/ 
Add.3 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 10 February 1999 
New Zealand IP/C/W/125/ 
Add.2 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 12 February 1999 
Hungary IP/C/W/125/ 
Add.1 Review of the Provisions of Article 27.3(b) -
Information from Members - Addendum 16 February 1999 
Bulgaria IP/C/W/125 Review of the Provisions of Article 27.3(b) -
Information from Members 3 February 1999 
 
LIST E - Information on the work of intergovernmental organizations 
2002 
UPOV IP/C/W/347/ 
Add.3 Review of the Provisions of Article 27.3(b), 
Relationship between the TRIPS Agreement 
and the Convention on Biological Diversity and Protection of Traditional Knowledge and Folklore 11 June 2002 
UNCTAD IP/C/W/347/ 
Add.2 Review of the Provisions of Article 27.3(b), 
Relationship between the TRIPS Agreement 
and the Convention on Biological Diversity and Protection of Traditional Knowledge and Folklore 10 June 2002 
CBD IP/C/W/347/ 
Add.1 Review of the Provisions of Article 27.3(b), 
Relationship between the TRIPS Agreement and the Convention on Biological Diversity and Protection of Traditional Knowledge and 
Folklore 10 June 2002 
FAO IP/C/W/347 Review of the Provisions of Article 27.3(b), 
Relationship between the TRIPS Agreement 
and the Convention on Biological Diversity and Protection of Traditional Knowledge and Folklore 7 June 2002 
2001 
WIPO IP/C/W/242 Statement by the World Intellectual Property 
Organization (WIPO) on Intellectual Property, Biodiversity and Traditional Knowledge 6 February 2001  IP/C/W/369/Rev.1 
 Page 35 
 
 
  LIST E - Information on the work of intergovernmental organizations 
2000 
UNCTAD IP/C/W/230 Document Prepared by the UNCTAD 
Secretariat for the Expert Meeting on 
Systems and National Experiences for Protecting Traditional Knowledge, Innovations and Practices which took place from 30 October to 1 November 2000 in 
Geneva:  Outcome of the Expert Meeting 14 December 2000 
International 
Bureau of WIPO IP/C/W/218 Document Prepared by the International 
Bureau of WIPO for the Meeting on Intellectual Property and Genetic Resources, which took place on 17 and 18 April 2000 in Geneva:  Intellectual Property and Genetic 
Resources - An Overview 18 October 2000 
International 
Bureau of WIPO IP/C/W/217 Document Prepared by the International 
Bureau of WIPO for the Roundtable on Intellectual Property and Traditional Knowledge, which took place on 1 and 2 November 1999 in Geneva:  Protection of Traditional Knowledge:  A Global 
Intellectual Property Issue 18 October 2000 
1999 
CBD IP/C/W/130/ 
Add.1 Review of the Provisions of Article 27.3(b) - 
Information from Intergovernmental Organizations  - Addendum 16 March 1999 
FAO IP/C/W/130/ 
Add.2 Review of the Provisions of Article 27.3(b) - 
Information from Intergovernmental Organizations  - Addendum 12 April 1999 
UPOV IP/C/W/130 Review of the Provisions of Article 27.3(b) - 
Information from Intergovernmental Organizations   17 February 1999 
 
LIST F - Notes by the Secretariat 
2003 
IP/C/W/273/ 
Rev.1 Review of the Provision of Article 27.3(b):  Illustrative List 
of Questions Prepared by the Secretariat - Revision 18 February 2003 
2002 
IP/C/W/370 The Protection of Traditional Knowledge and Folklore - 
Summary of Issues Raised and Points Made 8 August 2002 
IP/C/W/369 Review of the Provisions of Article 27.3(b) - Summary of 
Issues Raised and Points Made 8 August 2002 
IP/C/W/368 The Relationship between  the TRIPS Agreement and the 
Convention on Biological Diversity - Summary of Issues 
Raised and Points Made 8 August 2002 
JOB(02)/60 The Protection of Trad itional Knowledge and Folklore - 
Summary of Issues Raised and Points Made 18 June 2002 
JOB(02)/59 Review of the Provision of Article 27.3(b) - Summary of 
Issues Raised and Points Made 18 June 2002 IP/C/W/369/Rev.1 
Page 36  
 
  LIST F - Notes by the Secretariat 
JOB(02)/58 The Relationship between  the TRIPS Agreement and the 
Convention on Biological Diversity - Summary of Issues Raised and Points Made 18 June 2002 
 2001  
Job No. 2689 
IP/C/W/273 Review of the Provisions of Article 27.3(b):  Synoptic Tables 
of Information provided by Memb ers - Informal Note by the 
Secretariat 5 June 2001 
 2000  
JOB(00)/7517 The Relationship between the Convention on Biological 
Diversity and the TRIPS Agreement:  Checklist of Points Made - Note by the Secretariat 23 November 2000 
 1999  
Job no. 2627 UPOV-WIPO-WTO Joint Symposium on the Protection of 
Plant Varieties under Article 27.3(b) of the 
TRIPS Agreement:  Texts of presentations 7 May 1999 
 1998  
IP/C/W/122 Illustrative Questions:  Review of the Provisions of 
Article 27.3(b) 22 December 1998 
 
__________